NIH_SPENDING_CATS: Clinical Research;Hematology;Rare Diseases;Sickle Cell Disease

ORG_CITY: DETROIT

ORG_DEPT: PHARMACOLOGY

ORG_NAME: WAYNE STATE UNIVERSITY

ORG_STATE: MI

PHR: Narrative Hydroxyurea (HU) is effective in decreasing the frequency of vaso-occlusive episodes (VOEs) in sickle cell disease (SCD), in part by reducing adhesion receptor expression and red cell-endothelial interactions; however, mechanisms involved are poorly understood. Sickle reticulocytes contribute to VOEs by participating in a series of adhesive events mediated by cell surface adhesion molecules elevated in the SCD microenvironment. This application will determine HU mechanisms that reduce red cell- endothelial interactions that precede VOEs in SCD.

PI_NAMEs: WHITE, JENNELL  (contact)

PROGRAM_OFFICER_NAME: LOUDEN, ANDREW

PROJECT_TERMS: adhesion receptor;Adhesions;Adhesives;Affect;Affinity;Affinity Chromatography;Alternative Therapies;American;Antibodies;Area;Area Under Curve;Basic Science;Binding;Biological Assay;Biological Availability;Blood flow;Blood specimen;Blood Vessels;career;career development;Caring;CD34 gene;Cell Adhesion;Cell Adhesion Molecules;Cell surface;Cells;cellular targeting;Clinical;Communication;Coupled;Cyclic GMP;Cytolysis;Data;Development;disease phenotype;effective therapy;Effectiveness;Endothelial Cells;Erythroblasts;Erythrocytes;Erythroid;Event;experience;Fetal Hemoglobin;Flow Cytometry;Fluorescence;Frequencies;Goals;Harvest;Health Care Costs;Hematopoietic stem cells;Hemoglobin concentration result;Hemoglobinopathies;hydroxyurea;Immunoprecipitation;improved;In Vitro;indexing;insight;Integrin alpha4beta1;Integrins;Knowledge;Leadership;Leukocytes;Ligands;Liquid Chromatography;magnetic beads;Mass Spectrum Analysis;Measures;Mediating;Mendelian disorder;Mentored Research Scientist Development Award;Mentors;Mentorship;Methods;Molecular;Molecular Conformation;Molecular Target;Monoclonal Antibodies;new therapeutic target;Nitric Oxide;novel;Outcome;Pathway interactions;Patients;Pharmaceutical Preparations;Phosphorylation;Phosphotransferases;Post-Translational Protein Processing;Production;protein protein interaction;Proteins;Proteome;Protocols documentation;receptor expression;receptor function;Recombinant Proteins;Reporting;Research Personnel;Research Proposals;response;Reticulocytes;Risk;Role;Sampling;Series;Severities;Severity of illness;Sickle Cell;Sickle Cell Anemia;Sickle Hemoglobin;sickling;Signal Pathway;Signal Transduction;skills;standard of care;Standardization;symptomatic improvement;tandem mass spectrometry;Testing;TFRC gene;Training;Trypsin;Up-Regulation;Vascular Cell Adhesion Molecule-1;Vascular Endothelial Cell;Whole Blood

PROJECT_TITLE: Identifying Mechanisms Involved in Hydroxyurea-Mediated Reduction in Vaso-occlusive Adhesive Events in Sickle Cell Disease


ADMINISTERING_IC: GM

ARRA_FUNDED: N

ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Clinical Research;Pediatric;Rural Health;Social Determinants of Health

ORG_CITY: ATLANTA

ORG_COUNTRY: UNITED STATES

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_FIPS: US

ORG_NAME: GEORGIA INSTITUTE OF TECHNOLOGY

ORG_STATE: GA

PHR: Project Narrative The goal in this work is to develop a new initiative, Frugal Science Academy (FSA), to empower underrepresented minority students and teachers from rural schools in Georgia to engage in synthetic biology, where the traditional bottleneck has been the lack of affordable scientific equipment for hands-on STEM. The Frugal Science Academy will train young URM high school investigators to develop “frugal hardware” (from concept to publication) used in synthetic biology research and disseminate their research into underequipped labs while also training rural high school teachers to incorporate synthetic biology education and frugal hardware into their curricula. This work will increase the diversity, creativity, and innovation in the rapidly expanding field of synthetic biology, with an emphasis on affordability and accessibility through the lens of frugal science, helping to democratize access to scientific tools.

PI_NAMEs: BHAMLA, SAAD  (contact)

PROGRAM_OFFICER_NAME: FAUPEL-BADGER, JESSICA

PROJECT_TERMS: 3D Print;Academy;Address;Adoption;African American student;Award;biological research;Biomedical Engineering;Biomedical Research;Biotechnology;Budgets;Capital;career;Clustered Regularly Interspaced Short Palindromic Repeats;Collaborations;Communities;Conscious;cost;course development;Creativeness;Democracy;design;Development;digital;Drops;Education;education resources;educational atmosphere;Educational Curriculum;Educational workshop;empowerment;Engineering;Environment;Equipment;experience;experimental study;Exposure to;Festival;fundamental research;Funding;genome editing;genome sequencing;Goals;hands on research;hands-on learning;health application;high school;High School Faculty;High School Student;Human;Human Genome Project;Hybrids;Infrastructure;innovation;Institution;Internships;invention;Laboratories;laboratory equipment;Learning;lens;maker-faire;meetings;member;Methods;Microscope;Mission;Modern 1601-history;Molecular;Molecular Biology;Names;next generation;novel;nucleotide metabolism;online course;Paper;Pathway interactions;portability;posters;Prize;Publications;Reproducibility;Research;Research Institute;Research Personnel;Research Project Grants;Resource-limited setting;Resources;response;RNA vaccine;Rural;rural area;Rural Developments;Schools;Science;science education;Scientific Advances and Accomplishments;skill acquisition;socioeconomics;STEM field;student training;Students;success;symposium;synthetic biology;Talents;teacher;Teacher Professional Development;Technology;tool;Training;Training and Education;Translations;trend;undergraduate student;Underrepresented Minority;underrepresented minority student;Underrepresented Populations;United States National Institutes of Health;Universities;virtual;Work

PROJECT_TITLE: Frugal Science Academy: Training K-12 innovators and democratizing synthetic biology tools

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-H(55)R]


ADMINISTERING_IC: HL

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Acute Respiratory Distress Syndrome;Clinical Research;Emergency Care;Lung;Physical Injury - Accidents and Adverse Effects;Rare Diseases

ORG_CITY: Aurora

ORG_DEPT: ANESTHESIOLOGY

ORG_NAME: UNIVERSITY OF COLORADO DENVER

ORG_STATE: CO

PHR: PROJECT NARRATIVE Later deaths after trauma are frequently attributable to endotheliopathy of trauma (EOT), an inflammatory state of microcirculation leak and tissue edema, contributing to acute respiratory distress syndrome (ARDS), multi- organ dysfunction, and, eventually, death. Fibrinogen replacement restores the endothelial glycocalyx in vitro and in mice via stabilization of syndecan-1; however, it is unclear if fibrinogen-based restoration of endothelial integrity translates to improved clinical outcomes in humans. This proposal will leverage our knowledge of EOT to investigate an innovative, endothelial restorative approach to mitigate trauma-induced multi-organ and pulmonary dysfunction.

PI_NAMEs: DOUIN, DAVID J. (contact)

PROGRAM_OFFICER_NAME: KALANTARI, ROYA

PROJECT_TERMS: Accounting;Acute Respiratory Distress Syndrome;Address;Anesthesiology;Area Under Curve;Blood flow;Cardiovascular system;career;career development;Cause of Death;Cessation of life;Clinical;Clinical Research;Clinical Trials;Coagulation Process;Critical Care;Critical Illness;Darkness;Data;Data Analyses;Dedications;Edema;Emergency Medicine;Endothelial Cells;Endothelium;Ensure;experience;Exposure to;Fibrinogen;Functional disorder;Funding;Future;Glycocalyx;Goals;Grant;Hemorrhagic Shock;Heparitin Sulfate;Hospitals;Hour;Human;Impairment;improved;improved outcome;In Vitro;Inflammatory;Injury Severity Score;innovation;Intervention;Kidney;Knowledge;Lung;lung injury;Manuscripts;Measures;Mentors;Mentorship;Microcirculation;Microscopy;Modality;Morbidity - disease rate;mortality;multidisciplinary;Mus;National Heart, Lung, and Blood Institute;novel;Operative Surgical Procedures;Organ;Organ Preservation;Outcome;Patient-Focused Outcomes;Patients;Persons;Physicians;Plasma;Positioning Attribute;preservation;prevent;prospective;Prospective, cohort study;Proteoglycan;Protocols documentation;Qualifying;Research;research and development;Research Infrastructure;respiratory;response;restoration;Sampling;Scientist;secondary outcome;success;supplemental oxygen;syndecan;Testing;Tissues;Training;Transfusion;Translating;Translational Research;Trauma;trauma care;trauma centers;Trauma patient;trauma surgery;Traumatic injury;United States National Institutes of Health;Ventilator;Whole Blood;Work

PROJECT_TITLE: Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ Dysfunction

STUDY_SECTION: MPOR

STUDY_SECTION_NAME: NHLBI Mentored Patient-Oriented Research Study Section[MPOR(MA)]


ADMINISTERING_IC: NS

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: NOTRE DAME

ORG_NAME: UNIVERSITY OF NOTRE DAME

ORG_STATE: IN

PHR: The proposed research is relevant to public health because glial cells, including astrocytes, are the most prevalent cell type in the brain and are associated with a host of neurodevelopmental and other diseases and disorders. Our goal of identifying the mechanism of astrogenesis in cortical folding is strongly aligned with the NINDS search for fundamental knowledge about the brain and, long-term, our experimentally-validated computational model will support the mission to reduce the burden of neurological disease.

PI_NAMEs: HOLLAND, MARIA  (contact)

PROGRAM_OFFICER_NAME: RIDDLE, ROBERT D

PROJECT_TERMS: Area;Astrocytes;Autocrine Communication;Behavior;Biochemical;Biological;biomechanical model;Brain;Calibration;cell behavior;Cell Density;Cell division;cell motility;cell type;Cells;Central Nervous System;Cerebrum;Collaborations;computer framework;Computer Models;cost;Coupled;Couples;data modeling;Development;Developmental Process;Diagnostic;Disease;effective therapy;Electroporation;Event;experience;Experimental Designs;experimental study;Ferrets;Functional disorder;Genetic;Goals;Growth;Health;Image;in silico;in utero;in vivo;Infection;insight;Investigation;Knowledge;Measures;mechanical force;Mechanics;Mission;Modeling;Molecular;Morphology;Motion;National Institute of Neurological Disorders and Stroke;Nerve Degeneration;Nervous System Disorder;Neurodevelopmental Disorder;Neuroglia;Neuroimmune;Neuronal Plasticity;Neurons;Neurosciences;novel;Oligodendroglia;Pathologic Processes;Pathway interactions;Pattern;Physiological Processes;Play;Population;prenatal;Process;Proliferating;Public Health;Publications;Research;response;risk prediction;Role;spatiotemporal;Structure;subventricular zone;Surface;Testing;Time;Tissues;white matter;Work

PROJECT_TITLE: CRCNS: Defining the role of astrogenesis in cortical folding

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-BN-P(50)R]


ADMINISTERING_IC: AA

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Brain Disorders;Machine Learning and Artificial Intelligence;Neurosciences;Substance Misuse

ORG_CITY: LUBBOCK

ORG_NAME: NEMALIFE INC.

ORG_STATE: TX

PHR: Project Narrative Alcohol use disorders (AUDs) are one of the most globally prevalent behavioral conditions and are responsible for over 140,000 deaths annually in the US. Unlike existing FDA-approved therapies, non-hallucinogenic psychedelics and their derivatives offer a paradigm shift in addiction treatment because they induce long-lasting abstinence after a single dose. Our Phase 1 project combines NemaLife’s microfluidic in vivo screening platform with AI to accelerate the discovery of new psychedelic-based therapeutics for AUDs.

PI_NAMEs: QURESHI, MOHAMMED ADNAN MOHAMMED HANIF (contact)

PROGRAM_OFFICER_NAME: FALK, DANIEL EVAN

PROJECT_TERMS: Abstinence;acamprosate;Acceleration;addiction;Address;Adverse effects;Agar;Age;alcohol abstinence;alcohol abuse therapy;Alcohol dependence;alcohol use disorder;alcohol-related death;Alcohols;analog;Animal Behavior;Animal Model;Animals;Behavior;Behavior Disorders;Behavioral;Biological Assay;Biological Sciences;Brain;Caenorhabditis elegans;Cessation of life;chemical synthesis;Chronic;clinical risk;Clinical Trials;compulsion;Custom;Data;Development;Disulfiram;Dose;drug discovery;drug use screening;economic cost;effective therapy;Elements;Exhibits;FDA approved;feeding;Future;Hallucinogens;Heavy Drinking;high dimensionality;high throughput screening;high-throughput drug screening;Humidity;Ibogaine;Image;improved;in vivo;Incidence;Individual;innovation;Invertebrates;Knowledge;Laboratories;lead candidate;Libraries;Lighting;Machine Learning;machine learning algorithm;Mammals;Marketing;Microfluidic Microchips;Microfluidics;Modeling;Naltrexone;Nematoda;neurobehavioral disorder;next generation;novel;novel therapeutics;Pharmaceutical Preparations;Phase;Phenotype;Population;Process;programs;Property;Protocols documentation;Publishing;Pump;Risk;Rodent Model;Safety;screening;Self Administration;sensor;Series;side effect;societal costs;Source;Substance Use Disorder;System;Temperature;Testing;Therapeutic;Time;Training;transcriptomic profiling;transcriptomics;United States;Validation;validation studies;Video Recording;Visual;Work

PROJECT_TITLE: Development of an AI-assisted therapeutic discovery platform for Alcohol Use Disorders using an invertebrate model

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Cancer;Cancer Genomics;Clinical Research;Clinical Trials and Supportive Activities;Genetics;Human Genome;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Precision Medicine

ORG_CITY: MORRISVILLE

ORG_NAME: VINDHYA DATA SCIENCE INC.

ORG_STATE: NC

PHR: PROJECT NARRATIVE RNA sequencing data yield powerful biomarkers for precision medicine, however there is a gap in the lack of software platforms to facilitate testing such biomarkers in the clinic. Our proposal is to develop methods to translate preclinical RNAseq biomarkers for clinical use, and to develop a comprehensive set of backend cloud-based infrastructure to enable rapid deployment of software platforms to support biomarker-driven trials. Our platform will address a much-needed solution to advance precision medicine.

PI_NAMEs: REDDY, ANUPAMA  (contact)

PROGRAM_OFFICER_NAME: RAJAGOPAL, MEENA UMA

PROJECT_TERMS: Address;analysis pipeline;Automation;Bioinformatics;Biological Markers;biomarker development;biomarker driven;Cancer Patient;Catalogs;Classification;Client;Clinic;Clinical;Clinical Trials;Clinical Trials Design;cloud based;cloud platform;Computer software;cost;cost effective;Custom;Data;Data Security;Data Set;Database Management Systems;design;Development;Elasticity;Face;Feedback;Funding;Future;Gene Expression;Genes;genetic signature;genomic biomarker;Goals;Immunotherapy;improved;Infrastructure;Interview;Intuition;Learning Module;Logistic Regressions;Logistics;Machine Learning;machine learning model;machine learning prediction;Marketing;Methods;Monitor;Mutation;mutational status;neural network;Oncology;optimal treatments;Outcome;Output;Patient Selection;Patients;Phase;pre-clinical;precision medicine;Precision medicine trial;preclinical study;predicting response;Prediction of Response to Therapy;Price;prototype;Publishing;Questionnaires;random forest;Renal Carcinoma;Reproducibility;Research;Research Personnel;response;RNA;RNA analysis;Running;Security Measures;Site;Specific qualifier value;System;Testing;Time;tool;transcriptome sequencing;Translating;Validation

PROJECT_TITLE: BIOCLIN: A precision medicine platform to support biomarker-driven clinical trials

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (14)]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Genetics

ORG_CITY: SAN DIEGO

ORG_NAME: ALIDA BIOSCIENCES, INC.

ORG_STATE: CA

PHR: Project Narrative Alida Biosciences is a start-up company focused on reading the epitranscriptomic code, a regulatory layer of biological information controlling how the genetic code is used in cells when healthy and during disease progression. By creating and commercializing the first platform for reading multiple elements of this epitranscriptomic code simultaneously, we will enable new science to understand the progression of diseases such as cancer, identify novel diagnostic biomarkers, and accelerate drug development targeting epitranscriptomic pathways.

PI_NAMEs: MILES, ZACHARY  (contact)

PROGRAM_OFFICER_NAME: CHO, THOMAS Y

PROJECT_TERMS: Acceleration;Affinity;Alternative Splicing;analytical method;Antibodies;Architecture;Award;Bar Codes;base;Binding;Bioinformatics;Biological;Biological Assay;Biological Sciences;Biology;Biotechnology;Cells;Chemicals;Chemotherapy-Oncologic Procedure;Clinical;cloud based;Code;combinatorial;commercial application;commercialization;cost;Data;data handling;Data Set;density;design;Detection;detection assay;diagnostic biomarker;Discrimination;Disease Progression;Diversity Library;drug development;Drug resistance;Elements;Endonuclease V;Engineering;Ensure;Environmental Risk Factor;epitranscriptome;epitranscriptomics;Evaluation;Evolution;Feedback;Foundations;Future;G-substrate;Genetic Code;Genetic Transcription;genomic platform;Goals;Grant;improved;in silico;In Vitro;Inosine;Investigation;Libraries;Malignant Neoplasms;Marketing;Measures;Medicine;melting;Messenger RNA;Methodology;Methods;Modeling;Modification;multiplex detection;Mutation;nano;Needle biopsy procedure;novel;novel diagnostics;Nucleic Acids;Outcome;Pathway interactions;Peptides;Performance;Phase;Process;product development;Property;Protein Engineering;Proteins;Pseudouridine;Questionnaires;rapid growth;Reaction;Reader;Reading;Reproducibility;RNA;RNA Folding;RNA-Protein Interaction;Role;Sampling;Scheme;Science;Site;Small Business Innovation Research Grant;Specificity;Standardization;success;technology platform;Temperature;Testing;trafficking;Transcript;Translations;tumor progression;usability;user-friendly;Validation;Virus Diseases;Work;Yeasts

PROJECT_TITLE: Engineered RNA Modification Recognition

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Multiple Sclerosis;Neurodegenerative;Neurosciences

ORG_CITY: NEW YORK

ORG_NAME: MICROSTRUCTURE IMAGING, INC.

ORG_STATE: NY

PHR: PROJECT NARRATIVE There is a dire need to better track the highly variable disease progression in patients with Multiple Sclerosis (MS), the most prevalent chronic inflammatory disease of the central nervous system (CNS), affecting at least 400,000 people in the United States. Current non-invasive MRI biomarkers of MS used in clinic and clinical trials include lesion load (number and volume of lesions), or brain volume atrophy (which is accelerated in MS brains), yet these coarse measures only change slowly over time and they are insensitive to the occult widespread neurodegeneration and inflammation of the normal appearing white matter in MS. In this project, we will develop a concise multiple sclerosis microstructural imaging (ms-MICSI) report, based on clinically feasible and widely available diffusion MRI scans, to quantify the microstructural damage to the normal appearing white matter related to microglial activation, axonal beading, axonal demyelination, and axonal loss, which provides a tool for Neurologists to intervene earlier and quantify MS progression in a more accurate and granular fashion as conventional volumetric biomarkers.

PI_NAMEs: LEMBERSKIY, GRIGORIY  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Acceleration;Adult;Affect;Age;Alzheimer's Disease;Atrophic;Axon;Biological Markers;Brain;brain volume;cellular pathology;Central Nervous System Diseases;chronic inflammatory disease;Clinic;Clinical;clinical practice;Clinical Trials;clinically relevant;Collaborations;commercialization;Computer software;Correlation Studies;cost;Data;Databases;Decision Making;Demyelinations;Diagnosis;Diffuse;Diffusion;Diffusion Magnetic Resonance Imaging;disability;Disabling;Disease;Disease Progression;Disease remission;drug development;Environment;follow-up;Frustration;Functional disorder;Gender;glial activation;Healthcare;healthy volunteer;Histopathology;Image;image processing;imaging biomarker;immunoregulation;Impaired cognition;improved;in vivo;Incubators;Individual;individual patient;Infiltration;Inflammation;Inflammatory;Injury;Innovation Corps;Interview;Legal patent;Lesion;Magnetic Resonance Imaging;magnetic resonance imaging biomarker;Measurement;Measures;Methods;Microscopic;Migraine;Modeling;Monitor;MRI Scans;Multiple Sclerosis;Multiple Sclerosis Lesions;multiple sclerosis patient;Nerve Degeneration;neuroinflammation;Neurologist;New York;Parameter Estimation;Pathologic;Pathology;Patients;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Physicians;Population;Positioning Attribute;Primary Progressive Multiple Sclerosis;Process;prognostic;Prognostic Marker;Property;Pythons;Reference Standards;Relapse;Relapsing-Remitting Multiple Sclerosis;remyelination;Reporting;Reproducibility;Research;research and development;Resources;Scanning;Secondary Progressive Multiple Sclerosis;sex;Signal Transduction;Software Engineering;Standard Model;standard of care;Stroke;structural imaging;Structure;Surrogate Markers;System;Time;Tissues;tool;United States;United States National Institutes of Health;Universities;verification and validation;Water;white matter

PROJECT_TITLE: Reporting Quantitative Microstructural MRI Metrics to Stage and Monitor Multiple Sclerosis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-C (10)]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Breast Cancer;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Prevention;Women's Health Research

ORG_CITY: NEWARK

ORG_NAME: MALCOVA INC

PHR: Project Narrative Breast cancer is the common type of aggressive cancer among women. The widespread cancer screening has reduced the mortality of this disease. Nevertheless, the gains are highly dependent on the specificities of the breast anatomy. The breast imaging community is very aware of the limitations of mammography and breast tomosynthesis (limited angle x-ray tomography of the breast) in regard to breast cancer detection, especially in the dense and extremely dense breast women. As a result, additional breast imaging modalities are used with increasing frequency, but there is no standalone imaging modality for addressing the dense breast issue. Breast ultrasound solutions are used in various settings but are limited in that they augment mammography. Breast MRI solutions are effective but costly to acquire and maintain. Dedicated breast CT has been studied at several sites with promising results. However, the inherent shortcomings of the current renditions of breast CT have hindered its clinical impact. We have devised a new methodology of CT image acquisition (dubbed narrow-beam CT) with the specific aim of resolving the dense breast problem. Through the Phase I period of this Phase II project, we built and tested a prototype narrow-beam CT system. A final version of this modality is currently being assembled in the laboratory. This new R44 grant proposal seeks to develop the finishing touches on the necessary hardware, perform necessary advancements in software. In addition, we will perform a first-in-patient pilot study to gain insight about the viability of this solution through clinical comparisons between breast CT and mammography/tomosynthesis in non-contrast (screening) setting, and comparisons between contrast enhanced breast CT and contrast enhanced MRI in diagnostic settings.

PI_NAMEs: GHAZI, PEYMON  (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: 3-Dimensional;Achievement;Address;Anatomy;Applications Grants;Architecture;attenuation;Awareness;Benign;Biopsy;Breast;Breast biopsy;Breast Cancer Detection;breast density;breast imaging;Breast Magnetic Resonance Imaging;Breast Microcalcification;Cancer Detection;cancer diagnosis;Clinical;commercialization;Communities;Computer software;Computing Methodologies;contrast enhanced;contrast enhanced computed tomography;cost;Data;Dedications;design;Detection;Development;Devices;Diagnostic;Digital Breast Tomosynthesis;Digital Mammography;Disease;Dose;Electronics;Evaluation;Feasibility Studies;Frequencies;Goals;Hybrids;Image;Image Guided Biopsy;image reconstruction;Imaging Device;imaging modality;imaging system;Imaging technology;Immobilization;improved;Injections;Inpatients;insight;Laboratories;Legal patent;Lesion;Magnetic Resonance Imaging;Malignant - descriptor;Malignant Breast Neoplasm;Malignant Neoplasms;Mammary Gland Parenchyma;Mammary Ultrasonography;Mammography;Methodology;Methods;Modality;mortality;Noise;novel;Outcome;Output;Patients;Performance;Phase;photon-counting detector;Pilot Projects;Property;Prospective Studies;prototype;R44 grant;reconstruction;Reporting;Resolution;Roentgen Rays;sample fixation;Scanning;screening;Screening for cancer;Series;Shapes;Site;Small Business Innovation Research Grant;Specificity;Structure;System;Technology;temporal measurement;Testing;Time;tomography;tomosynthesis;Touch sensation;ultrasound;United States;Validation;Woman;X-Ray Computed Tomography;X-Ray Tomography

PROJECT_TITLE: A comprehensive imaging solution for dense breast cancer screening and diagnostics

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-Z (10)]


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Patient Safety;Rehabilitation

ORG_CITY: AUSTIN

ORG_NAME: HEALTH DISCOVERY LABS LLC

PHR: 80% of mechanically ventilated patients in the US develop some form of neuromuscular dysfunction resulting in ICUAW. Efforts to reduce this burden have been hindered by the lack of an effective tool facilitating the adoption of early mobility. The goal of the project is to develop a safe and easy to use electrical muscle stimulation device to facilitate the adoption of early mobility therapy within few hours of ICU admission.

PI_NAMEs: HASSAN, OUSSAMA  (contact)

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: Acute;Address;Admission activity;Adoption;Adrenal Cortex Hormones;adverse event risk;Affect;Antibiotics;Bed rest;bioelectricity;biomaterial compatibility;Cardiac;cardiac implant;Clinical Data;Clinical Trials;commercial prototype;commercialization;comparison control;Computer software;Control Groups;Critical Illness;Data;Death Rate;design;Detection;Development;Devices;Diagnosis;Direct Costs;effective therapy;Electric Stimulation;Electrocardiogram;Electrodes;Electromagnetics;Electronics;Environment;Equipment;Exclusion;Exercise;Exposure to;External Defibrillator;Feasibility Studies;Feedback;Functional disorder;Functional impairment;Goals;group intervention;Health;Healthcare Systems;healthy volunteer;hemodynamics;Hospitalization;Hour;improved;Inflammatory;interest;Intervention;intervention cost;Length of Stay;Life;Limb structure;Literature;Lower Extremity;Measurement;Measures;Mechanical ventilation;Mechanics;Medical Device;meetings;Monitor;monitoring device;Muscle;Muscle Contraction;muscle strength;neuromuscular;Neuromuscular Blocking Agents;Noise;Palpable;Patient Admission;Patient Compliance;Patients;pharmacologic;Phase;Physical therapy;Physiologic pulse;Physiological;Pilot Projects;Polychlorinated Biphenyls;preservation;prevent;Preventive measure;Process;programs;prototype;Quality of life;Rehabilitation therapy;research and development;Respiratory Muscles;response;Rhabdomyolysis;Risk;Risk Reduction;Safety;safety and feasibility;safety study;safety testing;Section 8;Sensory;septic patients;Signal Transduction;Site;skills;Skin;Small Business Innovation Research Grant;Surface;System;Testing;Time;tool;usability;Validation;verification and validation;Weaning;Work;Workload

PROJECT_TITLE: Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-A (11)]


ADMINISTERING_IC: CE

IC_NAME: NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

ORG_CITY: STAMFORD

ORG_NAME: KINIMA, INC.

ORG_STATE: CT

PHR: Fall prevention represents a public health priority, afflicting 1 in 4 senior adults at a cost of over $50 billion annually, and leading to declines in quality of life and inability to age in place for many older adults. Existing fall prevention modalities can be labor intensive, difficult to scale, inaccessible to certain underserved populations, and difficult to track adherence and outcomes, creating an opportunity for a technology-enabled fall prevention platform to improve access, adherence, and ultimately the trifecta of fall prevention: strength, balance, and gait improvement. KINIMA Seniors At Home provides a mobile assistive technology for fall prevention in older adults, including underserved segments, leveraging computer vision, augmented reality, robust content, automated data collection, and a novel user interface in a revolutionary cost-effective approach to greatly scale and commercialize this technology-powered platform for fall prevention activities, with the ultimate goal of improved health outcomes, increased aging at home with less injuries, enhanced good health and higher quality of later life.

PI_NAMEs: MIGDAL, RENEE  (contact)

PROJECT_TITLE: SBIR, Augmented Reality Personalized Motion Tracking, Assessment, and Improvement Technology for Fall Prevention With Seniors Living in Subsidized Housing Using a Mobile Phone

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BP-C (10)]


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Genetics;Hematology;Human Genome;Lymphatic Research;Lymphoma;Precision Medicine;Rare Diseases

ORG_CITY: Peachtree Corners

ORG_NAME: KASA BIO, L.L.C.

PHR: Project Narrative Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL). There are two major biologically distinct molecular subtypes of DLBCL, germinal center B-cell (GCB) and activated B- cell (ABC). Differentiation of these subtypes is crucial for the right treatment. The goal of this SBIR phase I proposal is to develop a Zip-MeltTM DLBCL Classifier Assay to differentiate these subtypes using Zip-MeltTM Multiplex Probe Technology in a single qPCR reaction. This high multiplex assay will be quicker, simple to perform, cost-effective, and will address the molecular diagnostic need, especially, for resource limited setting and will be ecofriendly.

PI_NAMEs: MADANAHALLY DIVAKAR, KIRAN  (contact)

PROGRAM_OFFICER_NAME: BILLINGSLEA, EDDIE

PROJECT_TERMS: Agreement;Archives;B-Cell Activation;B-Lymphocytes;Biological Assay;Buffers;cancer diagnosis;Cell Line;Chemicals;Chemistry;Classification;Clinic;Clinical;clinical practice;clinical prognostic;clinically significant;Color;commercialization;companion diagnostics;Computer software;cost;cost effective;design;Detection;detection limit;detection platform;Development;Diagnosis;Diagnostic;digital;Disease;DNA;Experimental Designs;Fluorescent Probes;Foundations;Future;Gene Expression;Gene Expression Profile;Gene Expression Profiling;Genes;Genetic Markers;genetic signature;Genomic DNA;Goals;Health Care Costs;Histocytochemistry;hospital laboratories;Human;Immune;Immuno-Chemotherapy;interest;isothermal amplification;large cell Diffuse non-Hodgkin's lymphoma;Lymphoma;Malignant Neoplasms;Measures;Messenger RNA;Methodology;Methods;molecular diagnostics;molecular subtypes;Monitor;multiplex assay;multiplex detection;nano-string;Non-Hodgkin's Lymphoma;novel;Oligonucleotides;Oncology;Outcome;outreach;Patients;Performance;Phase;Plastics;Point-of-Care Systems;Reaction;Reagent;Recurrence;Refractory Disease;Relapse;Reproducibility;Residual state;Resource-limited setting;response;RNA;Sampling;Sensitivity and Specificity;Small Business Innovation Research Grant;Specimen;Structure of germinal center of lymph node;study characteristics;System;Technology;Testing;Thermodynamics;Time;tool;wasting;Work

PROJECT_TITLE: A multiplex platform for quantitative analysis of clinically important gene expression signatures


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Infectious Diseases;Neurosciences;Urologic Diseases

ORG_CITY: WOODBURY

ORG_NAME: CATHBUDDY, INC.

PHR: The proposed project is relevant to public health because, while many individuals with neurogenic bladder require intermittent catheterization (IC) to urinate, the current standard of care (IC with single-use catheters) leads to high risk of urinary tract infection (UTI), is prohibitively expensive for many users, and produces large amounts of plastic waste. Our novel reusable no-touch catheterization system aims to utilize improved human factors design of a catheterization apparatus in combination with a personal portable washer-disinfector to improve the usability of IC, decrease the per-use cost of IC, and decrease contact contamination that leads to UTIs

PI_NAMEs: PAUL, SOUVIK  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Adopted;Bladder;Catheterization;Catheters;Cause of Death;clinical practice;Clinical Research;Communication;Communities;cost;Data;Dependence;design;Development;Development Plans;disabled;Disease;Drops;Environmental Impact;Equipment;FDA approved;Feedback;Female;Frequencies;Future;Goals;Guidelines;Health Care Costs;Healthcare Systems;high risk;Home;Human;improved;Incidence;Individual;infection rate;infection risk;Legal patent;Length;Life;Liquid substance;male;Medical;Medical Device;Methods;miniaturize;Modification;Morbidity - disease rate;Neurogenic Bladder;novel;Patients;Persons;Phase;Population;portability;prototype;Public Health;Pump;Quality of life;Recommendation;recruit;Secure;Self Administration;Small Business Innovation Research Grant;Spinal cord injury;standard of care;System;system architecture;Technology;Testing;Text;Touch sensation;Translating;Translations;United States;urinary;Urinary Catheterization;Urinary Retention;Urinary tract infection;usability;verification and validation;wasting;Water

PROJECT_TITLE: Feasibility, Pilot, and Communication studies towards Translation of Aurie Reusable Catheter System into Clinical Practice.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CCHI-J (10)]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Bioengineering;Complementary and Integrative Health;Dietary Supplements;Estrogen;Menopause;Nutrition;Women's Health Research

ORG_CITY: JOHNS CREEK

ORG_NAME: MOREMME VA LLC

PHR: PROJECT NARRATIVE Approximately 50% of post-menopausal women worldwide suffer from Vaginal Atrophy, a component of Genitourinary Syndrome of Menopause, which is a chronic, progressive condition occurring due to menopause- related estrogen deficiency. The work proposed in this application aims to optimize loading and release of Moremme’s natural, hormone-free bioactive gel formulations, assess biocompatibility in a human vaginal tissue model, and establish efficacy in a rodent model of Vaginal Atrophy. Our goal is to develop a safe, effective, hormone-free vaginal suppository as an alternate and more acceptable treatment option for women suffering from Vaginal Atrophy.

PI_NAMEs: AKANDE-DOKUN, JANET  (contact)

PROGRAM_OFFICER_NAME: FOX, JENNIFER THERESA

PROJECT_TERMS: 3-Dimensional;Address;Adoption;Affect;Aging;aging population;alternative treatment;Anti-Inflammatory Agents;Atopobium vaginae;Atrophic;Biological Assay;biomaterial compatibility;Cells;Chronic;Collagen;commercialization;cytokine;cytotoxicity;Data;Dementia;Development;Devices;Disease;Dose;Drug Delivery Systems;Dyspareunia;Effectiveness;efficacy evaluation;Elastin;Electrical Resistance;Enzyme-Linked Immunosorbent Assay;Epithelial Cells;Epithelium;Estradiol;Estrogen deficiency;Estrogen Therapy;Estrogens;Exhibits;Extracellular Matrix;Extracellular Matrix Proteins;Female;Fibroblasts;Formulation;Future;Gel;Gene Expression;Gene Proteins;Genitourinary system;Glycogen;Goals;healthy aging;High Pressure Liquid Chromatography;Homeostasis;hormone therapy;Hormones;Human;Hyaluronic Acid;Hydration status;improved;in vivo;Individual;Inflammatory;Interleukin-1 beta;Interleukin-10;Interleukin-6;Interleukins;irritation;Kinetics;Lasers;Lead;lead candidate;lead optimization;Legal patent;Lubricants;Malignant Neoplasms;Marketing;Matrix Metalloproteinases;Measures;Menopausal Syndrome;Menopause;minimally invasive;Modeling;Morphology;National Institute on Aging;novel;Ovariectomy;Pain;Pattern;Pectins;Pharmacological Treatment;Phase;Population;Postmenopause;prebiotics;Procedures;product development;Production;Proliferating;Proteins;prototype;Pruritus;Quality of life;Rattus;Recommendation;Recurrence;repaired;Risk;Rodent Model;Safety;safety assessment;Sexual Health;side effect;Sirius Red F3B;Small Business Innovation Research Grant;Sprague-Dawley Rats;Stains;Structural Protein;Symptoms;System;Testing;Thick;Thinness;Time;Tissue Model;Tissue Viability;Tissues;TNF gene;United States;Urinary tract infection;Uterus;Vagina;vaginal dryness;vaginal fluid;vaginal microbiome;Vaginal Suppository;water channel;Weight;Well in self;Woman;Work

PROJECT_TITLE: Hormone-Free Prebiotic Muco-Adhesive Gels To Treat Vaginal Atrophy in Post-Menopausal Women

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-S (10)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Nutrition;Obesity;Prevention;Racial and Ethnic Minority Health Research;Women's Health Research

ORG_CITY: DURHAM

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: DUKE UNIVERSITY

PHR: Contact PD/PI: Mitchell, Nia 3. PROJECT NARRATIVE The proposed research is relevant to public health because if a low-cost, community-based weight loss program with a national infrastructure is effective at both weight loss and improving physical function among elderly individuals with decreased physical function, it has the potential to reduce adverse geriatric outcomes. The proposed research is relevant to the part of the NIH mission that pertains to enhancing health and reducing illness and disability. Page 7 Project Narrative

PI_NAMEs: MITCHELL, NIA SCHWANN (contact)

PROGRAM_OFFICER_NAME: RADZISZEWSKA, BARBARA

PROJECT_TERMS: Academia;African American Women;Body Weight Changes;Body Weight decreased;cardiovascular disorder risk;Communities;cost;COVID-19 pandemic;Databases;Dietitian;disability;Effectiveness;Elderly;frailty;Funding;Goals;Health;health care service utilization;health disparity;High Prevalence;Human Resources;implementation intervention;improved;Individual;Infrastructure;innovation;Intervention;Mission;Obesity;Older Population;older women;Outcome;parent project;Participant;peer;Physical Function;Pilot Projects;programs;Public Health;Quality of life;Research;Risk Factors;study population;Testing;United States National Institutes of Health;Vulnerable Populations;Weight;weight loss intervention;weight loss program

PROJECT_TITLE: Supplement for Changes in Weight and Physical Function for Older African American Women in National, Peer-Led, Community-Based Weight Loss Program


NIH_SPENDING_CATS: Aging;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Neurodegenerative;Neurosciences;Parkinson's Disease

ORG_CITY: WEXFORD

ORG_NAME: NEURONASAL INC

ORG_STATE: PA

PHR: Narrative Parkinson’s Disease (PD) is a neurodegenerative disease with no known cure, and while current treatments can improve the quality of life for patients, there is no current treatment capable of slowing or preventing its progression. Entobee Therapeutics proposes to develop the first effective intranasal (IN) pharmacologic treatment for the management of PD. The proposed research will provide a more reliable neuroprotective treatment for PD patients.

PI_NAMEs: GREENE, DOUGLAS  (contact);VU, AN T

PROGRAM_OFFICER_NAME: CLARKE, AKANNI YAO

PROJECT_TERMS: Acetylcysteine;Address;Affect;Age;alpha synuclein;American;antioxidant therapy;Antioxidants;Anxiety;Basal Ganglia;Behavior Disorders;Benchmarking;Biological Availability;Blinded;Blood - brain barrier anatomy;Bradykinesia;Brain;Brain region;Bypass;Chronic;Chronic Care;Clinical;clinical application;Clinical Investigator;Clinical Research;Clinical Trials;Collaborations;Constipation;Corpus striatum structure;Cysteine;Cytoplasmic Inclusion;Deacetylation;design;Development;Diagnosis;Disease;disease diagnosis;dopamine transporter;dopaminergic neuron;Dose;Drug Kinetics;effective therapy;Exhibits;FDA approved;gastrointestinal;Genetic;Glutathione;Goals;Hepatic;Human;Human Volunteers;Impaired cognition;improved;In Situ;interest;Intervention;Intravenous;Intravenous infusion procedures;Magnetic Resonance Spectroscopy;Measures;Medical;Membrane Transport Proteins;Mental Depression;Metabolism;Midbrain structure;Mole the mammal;Nerve Degeneration;Neurodegenerative Disorders;Neuromodulator;neuroprotection;neurorestoration;neurotoxic;non-motor symptom;Nose;Nose Diseases;novel;Occipital lobe;Oral;Outpatients;oxidative damage;Parkinson Disease;pars compacta;Pathology;Patients;Persons;Pharmaceutical Preparations;Pharmacodynamics;Pharmacological Treatment;Phase;Placebo Control;posture instability;Prefrontal Cortex;preservation;prevent;Process;Prodrugs;Protons;Publishing;Quality of life;Randomized;Reporting;Research;Risk Factors;Role;Safety;sleep behavior;Smell Perception;Stream;Substantia nigra structure;Therapeutic;therapy development;Tremor;Trigeminal nerve structure;Universities;Work

PROJECT_TITLE: Circumventing the pharmacokinetic/pharmacodynamic limitations of antioxidant therapy for Parkinson's Disease by nose to brain delivery of N-acetylcysteine

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 AN-P (11)]


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Gene Therapy;Gene Therapy Clinical Trials;Genetics;Hematology;Immunotherapy;Infectious Diseases;Lymphatic Research;Lymphoma;Orphan Drug;Prevention;Rare Diseases

ORG_CITY: PITTSBURGH

ORG_NAME: CYTOAGENTS, INC.

PHR: Narrative Chimeric antigen receptor (CAR) T-cell therapy has emerged as a very promising treatment option for patients with relapsed or refractory hematologic malignancies, but it can also result in a high incidence of severe and potentially life-threatening immune-mediated toxicity, particularly cytokine release syndrome (CRS). The compound CTO1681, which has strong potential to reduce the CRS response by modulating the release of cytokines from human peripheral blood mononuclear cells, has shown promise as a treatment for moderate virus-induced CRS. This project will support the expansion of the clinical investigation of CTO1681 for the treatment of CAR T-cell therapy-induced CRS.

PI_NAMEs: BERTOLINO, ARTHUR P (contact)

PROGRAM_OFFICER_NAME: REGMI, SAROJ GOPAL

PROJECT_TERMS: Adverse event;analog;Arterial Occlusive Diseases;Asian;Blood Vessels;CAR T cell therapy;CD19 gene;Cells;chimeric antigen receptor T cells;Chronic;Clinical assessments;clinical investigation;Clinical Trials;cohort;Country;COVID-19;cytokine;cytokine release syndrome;Dangerousness;Data;Dinoprostone;Dose;Double-Blind Method;Drug Kinetics;Endothelial Cells;Epoprostenol;Etiology;Formulation;Functional disorder;Genetic Transcription;Healthcare Systems;healthy volunteer;Hematologic Neoplasms;Hospitalization;Human;Immune;immune effector cell-associated neurotoxicity syndrome;Immune response;improved;Incidence;Infection;Inflammatory;Influenza;Isomerism;large cell Diffuse non-Hodgkin's lymphoma;Letters;Life;Marketing;Mediating;Morbidity - disease rate;mortality;novel;novel strategies;open label;Oral;patient population;Patient-Focused Outcomes;Patients;Peripheral Blood Mononuclear Cell;Peripheral Vascular Diseases;pharmacologic;Pharmacologic Substance;Phase;Phase Ib Trial;Placebos;Platelet aggregation;Platelet Aggregation Inhibitors;prevent;Prevention;Prostaglandins I;pulmonary arterial hypertension;Quality of life;randomized placebo controlled study;receptor;Recommendation;Recording of previous events;Refractory;Relapse;Reporting;response;Safety;Schedule;Serum;Signal Transduction;Small Business Innovation Research Grant;Sodium;Stereoisomer;Supportive care;Synthetic Prostaglandins;systemic inflammatory response;T-Cell Receptor Therapy;Therapeutic;Toxic effect;tumor;Vasodilator Agents;Virus;WFDC2 gene;Work

PROJECT_TITLE: CTO1681 to prevent and mitigate cytokine release syndrome in CAR T-cell recipients

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-V (13)]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Cocaine;Drug Abuse (NIDA only);Genetics;Mental Health;Neurosciences;Stimulant Use and Misuse;Substance Misuse

ORG_CITY: PHILADELPHIA

ORG_NAME: EPIVARIO, LLC

PHR: Developing a novel epigenetic regulator as a treatment for cocaine use disorder NARRATIVE Cocaine is an addictive stimulant drug that is at the root of 1.3 million people in the US being afflicted with cocaine use disorder (CUD) and nearly 19,447 people dying from cocaine-related overdose in a recent year, which is even more alarming knowing there is no approved pharmacotherapies. The current standard of care for CUD consists of behavioral interventions including contingency management (i.e., motivational incentives), cognitive behavioral therapy, or therapeutic communities (i.e., drug-free residencies), which remain prone to noncompliance by the patients and have relapse rates of 20-25%. The problem is the intense cocaine-taking euphoria memories and the overwhelming urge that it causes; however, the pharmacotherapeutic we plan to develop will solve this problem by attenuating the problematic craving urge.

PI_NAMEs: KIM, THOMAS  (contact)

PROGRAM_OFFICER_NAME: KARUPPAGOUNDER, SARAVANAN SHANMUGAM

PROJECT_TERMS: Acetate-CoA Ligase;Acetyl Coenzyme A;Acute;addiction;ADME Study;Alcohols;Animal Model;Applications Grants;Automobile Driving;Behavior;Behavior Therapy;Behavioral;Binding;Biological Assay;Biological Availability;Brain;Characteristics;Chemicals;Clinical;Cocaine;Cocaine Dependence;cocaine overdose;cocaine self-administration;cocaine use;Cocaine use disorder;cofactor;Cognitive Therapy;contingency management;craving;Cues;Data;Development;Disease;drug candidate;drug craving;drug development;Drug Kinetics;Drug Targeting;Drug usage;effective therapy;efficacy testing;Enzymes;Epigenetic Process;Euphoria;Exhibits;Feeling;Gene Expression;Gene Expression Regulation;Generations;Genes;Genetic;Genetic Transcription;Half-Life;Hippocampus;Histone Acetylation;histone modification;Immediate-Early Genes;improved;In Vitro;in vitro Assay;in vivo;Incentives;Induced Neurons;inhibitor;innovation;Intravenous;knock-down;lead candidate;Learning;Legal patent;Link;long term memory;Medical;Memory;memory consolidation;memory recall;Metabolic;Modeling;Morbidity - disease rate;mortality;Motivation;Neuronal Plasticity;Nicotine;non-drug;novel;novel therapeutics;Opioid;Overdose;overdose death;Patient Noncompliance;Persons;Pharmaceutical Chemistry;Pharmaceutical Preparations;pharmacologic;Pharmacologic Substance;Pharmacotherapy;Play;pre-clinical;Pre-Clinical Model;Process;programs;Property;Public Health;Relapse;relapse prevention;Research;Residencies;Retrieval;Rodent;Rodent Model;Role;scaffold;Self Administration;Series;Short-Term Memory;small molecule inhibitor;standard of care;Stimulant;Stress;Substance abuse problem;substance misuse;Testing;Therapeutic;Therapeutic community technique;Time;United States

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-S (14)]


ADMINISTERING_IC: OD

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Dental, Oral, and Craniofacial Disease;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Homelessness;Social Determinants of Health

ORG_CITY: MINNEAPOLIS

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: UNIVERSITY OF MINNESOTA

ORG_STATE: MN

PHR: PROJECT NARRATIVE The proposed research will improve public health by producing high-quality, comparable local estimates of homeless mortality that can be used by states, local governments, and communities to appropriately allocate resources needed to address the homeless mortality crisis. Additionally, by investigating the association between place-based factors and homeless mortality, this project will provide insight into how local policies and programs might be optimized to improve health and reduce mortality among people experiencing homelessness.

PI_NAMEs: BERRY, KAITLYN M (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: access restrictions;Address;Age;American;Area;Award;career;Censuses;Cessation of life;Cities;Communities;Community Health;Community Surveys;community-level factor;Continuity of Patient Care;County;Data;Death Rate;Demography;design;Economic Conditions;Environment;Epidemiology;experience;Funding;geographic difference;Geography;Health;health care service;health equity;Health Services Accessibility;Homeless persons;Homelessness;improved;informant;innovation;insight;Interdisciplinary Study;Intervention;Interview;Lead;Link;Local Government;Location;medical schools;Mentorship;Methodology;Methods;Minnesota;Mission;mortality;mortality disparity;mortality risk;multilevel analysis;National Institute of Child Health and Human Development;National Institute on Minority Health and Health Disparities;novel;Persons;Policies;Policy Research;Population;population health;Positioning Attribute;professor;programs;protective factors;Provider;Public Health;Public Health Schools;Publishing;Quasi-experiment;Records;recruit;Research;Research Project Grants;residence;Resource Allocation;Resources;response;Risk;Risk Factors;Secure;senior faculty;service providers;Services;Shelter facility;Social Policies;Sociology;sound;symposium;System;Testing;Time;Training;United States National Institutes of Health;United States Social Security Administration;Universities;US State;Variant;Weather;Work

PROJECT_TITLE: Place-Based Influences on Mortality among People Experiencing Homelessness

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 HSS-E (70)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Prostate Cancer;Radiation Oncology;Urologic Diseases

ORG_CITY: CHAPEL HILL

ORG_NAME: TRIPILL BIOTECHNOLOGY, CORP.

PHR: Project Narrative The proposed research aims to develop PSMA agents that have selectively reduced radiation to salivary glands (SGs) while still maintaining tumoricidal effect during targeted radioisotope treatment. These innovative PSMA targeted agents are clinically translatable, which could lead to improved therapeutic response with reduced toxicity towards normal organs.

PI_NAMEs: WU, ZHANHONG  (contact)

PROJECT_TERMS: Address;Adverse effects;Affinity;antigen binding;Antigen Targeting;Binding;Biology;Biotechnology;Cations;Chemistry;Chronic;clinical practice;Clinical Research;clinical translation;commercial application;Data;Development;Diagnosis;Diagnostic;Diffuse;Disease;divinyl sulfone;Dose Limiting;dosimetry;Drug Delivery Systems;Elements;Eligibility Determination;Evaluation;Excretory function;Exposure to;FDA approved;FOLH1 gene;Foundations;Future;Goals;Half-Life;Hand;human subject;Image;imaging agent;imaging study;improved;in vivo;Injections;innovation;invention;Joints;Kidney;Label;Legal patent;Licensing;Ligands;Malignant neoplasm of prostate;Mediation;Metals;Modeling;molecular imaging;Monitor;Morphology;multidisciplinary;next generation;nonhuman primate;Organ;overexpression;patient screening;Patients;Phase;Positron-Emission Tomography;Preparation;prostate cancer model;Prostate Cancer therapy;Radiation;Radiation exposure;Radioactivity;Radiochemistry;Radioisotopes;Radiolabeled;Radionuclide therapy;Radiopharmaceuticals;receptor;Research;research clinical testing;Rodent;Rodent Model;saliva secretion;Salivary Glands;Site;Solid;Structure of base of prostate;success;System;targeted agent;targeted radiotherapeutic;targeted treatment;Technology;theranostics;Therapeutic;Therapeutic Agents;Therapeutic Effect;Therapeutic Uses;Tissues;Toxic effect;Translational Research;Treatment Efficacy;Treatment outcome;treatment response;tumor;uptake;Xerostomia

PROJECT_TITLE: The Development of Radiolabeled PSMA Agent with Low Salivary Gland Uptake

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CTH-E (11)]


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Emerging Infectious Diseases;Infectious Diseases;Prevention;Wound Healing and Care

ORG_CITY: Summit

ORG_NAME: SINGLETO2 THERAPEUTICS, LLC

ORG_STATE: NJ

PHR: Project Narrative To address the critical and longstanding problem of multidrug resistant (MDR) bacterial infections in burn wounds, we propose an innovative superhydrophobic (SH) antimicrobial photodynamic therapy (aPDT) bandage that not only prevents MDR infections but does so without introducing a drug into the site. Using visible light supplied by either an integrated or external LED light source, this bandage will prevent MDR infections acquired in the hospital, as well as MDR infections experienced by military personnel deployed in the field. The objective of this proposal is to design the bandage system and to validate its use ex vivo and in a mouse burn model.

PI_NAMEs: XU, QIANFENG  (contact)

PROGRAM_OFFICER_NAME: XU, ZUOYU

PROJECT_TERMS: absorption;Address;Adhesions;Adoption;Air Movements;Animals;Antibiotics;antimicrobial;Bacteria;Bacterial Infections;bacterial resistance;Bandage;burn model;burn wound;combat;Cream;design;Development;Devices;Disease;dosage;Ensure;Exclusion;experience;Family suidae;flexibility;Gases;Generations;Gram-Negative Bacteria;Gram-Positive Bacteria;healing;Hospitals;Human Resources;Hydrogels;in vivo;in vivo Model;Inbred BALB C Mice;Infection;Infection prevention;innovation;Length of Stay;Light;Liquid substance;Mammalian Cell;Methods;Military Personnel;Minocycline;Modeling;Molecular;mouse model;Multi-Drug Resistance;Multiple Bacterial Drug Resistance;Mus;novel therapeutic intervention;Operative Surgical Procedures;Oxygen;pathogenic bacteria;patient mobility;Patients;Periodontitis;Pharmaceutical Preparations;Phase;Photosensitizing Agents;Porosity;pressure;prevent;Prevention;Property;PUVA Photochemotherapy;Rattus;Resistance;Resistance development;Silver;Singlet Oxygen;Site;skin burn;Source;Sterile coverings;success;Sulfadiazine;Surface;Sus scrofa;System;Texture;Tissues;Treatment Cost;uptake;Visible Radiation;Work;wound;wound healing;Wound Infection

PROJECT_TITLE: A Compliant Superhydrophobic Antimicrobial Photodynamic Therapy Bandage for the Prevention of Multidrug Resistant Wound Infections

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-D (10)]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Biotechnology;Brain Disorders;Dementia;Nanotechnology;Neurodegenerative;Neurosciences

ORG_CITY: WOBURN

ORG_NAME: APHIOS CORPORATION

ORG_STATE: MA

PHR: PROJECT NARRATIVE Alzheimer's disease and dementia are debilitating diseases affecting over 6.7 million people in the United States and over 55 million people worldwide. Inflammation is implicated in many aging diseases and in the central nervous system (CNS) is associated with the CCR5 gene, that has been correlated with AD in aged mice, which was reversed with an FDA approved anti-CCR5 drug that inhibits this receptor. We propose to develop targeted nanoparticles of an anti-CCR5 drug, and evaluate their impact on brain inflammation and Alzheimer's disease.

PI_NAMEs: CASTOR, TREVOR P. (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Acceleration;Adult;Affect;Age;age related;aging related disease;Allergic Reaction;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease therapeutic;antagonist;Antineoplastic Agents;APP-PS1;aqueous;Biodistribution;Biotechnology;Blood - brain barrier anatomy;blood-brain barrier crossing;blood-brain barrier penetration;Brain;bryostatin;Bypass;Camptothecin;Central Nervous System;Characteristics;chemokine;chemokine receptor;Circulation;cytokine;Dementia;Development;Disease;Dose;Drug Kinetics;efficacy study;Encapsulated;Encephalitis;Enzymes;Ethanol;Europe;experience;FDA approved;Future;Genes;Genetic;Glucose;HIV;HIV Infections;HIV Receptors;HIV-1;Human;hydrophilicity;Hydrophobicity;IL17 gene;Impaired cognition;Impairment;In Vitro;in vitro Model;in vivo;Inflammation;Inflammatory;Interleukin-1 beta;Interleukin-6;Interleukins;Knock-out;Licensing;Life;Ligands;Link;Lipid Bilayers;lipid nanoparticle;Lipids;Liposomes;Liquid substance;Liver;Macrophage;manufacturing process;manufacturing scale-up;Mediating;memory consolidation;Mus;nanoparticle;nanoparticle drug;Nervous System Disorder;Neurodegenerative Disorders;Neurons;novel;old mice;Oral;particle;Performance;Persons;Pharmaceutical Preparations;pharmacologic;Pharmacologic Substance;Phase;Process;RANTES;receptor;Receptor Inhibition;Research Personnel;Residual state;Senile Plaques;side effect;Skin;Solvents;Structure;System;T-Lymphocyte;tau Proteins;Technology;Therapeutic;therapeutic target;therapeutically effective;Thermodynamics;Time;TNF gene;Toxic effect;Toxicology;transcytosis;Transferrin;Transgenic Mice;transgenic model of alzheimer disease;United States;vesicle transport;Vitamin D;Wild Type Mouse

PROJECT_TITLE: Development of a Novel Alzheimer's Disease Therapeutic


NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Immunotherapy;Neurosciences;Orphan Drug;Rare Diseases

ORG_CITY: MILWAUKEE

ORG_NAME: UP ONCOLYTICS, INC.

ORG_STATE: WI

PHR: Project Narrative Glioblastoma is incredibly fatal and difficult to treat - the same combination therapy has been in use for almost 20 years despite offering only very moderate extensions in patient survival. We are validating a therapeutic Zika virus that overcomes the barriers to treatment and, in background testing, demonstrates incredibly good efficacy and safety. In direct response to FDA feedback on our pre-IND submission, this proposal is designed to allow us to complete IND-enabling studies to gain approval for our novel new therapeutic which we believe will have dramatic impacts on patient outcomes.

PI_NAMEs: AKHTAR, PARVEZ  (contact)

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: Address;Animal Model;Animals;anti-cancer;antiviral immunity;barrier to care;Biodistribution;blood-brain barrier crossing;cancer cell;Cell Line;cell type;Cells;Cessation of life;Chemistry;chemotherapy;Chemotherapy and/or radiation;Clinic;Clinical;Clinical Trials;Combined Modality Therapy;commercialization;Communities;cost;cytotoxicity;Data;design;Development;Diagnosis;Disease remission;DNA;Dose;drug candidate;Enzymes;Excision;experimental study;Feedback;first-in-human;Future;Genetic;Glioblastoma;Glioma;Heterogeneity;Human;Human Cell Line;Immune response;Immunocompetent;Immunocompromised Host;Immunotherapy;improved;In Vitro;in vivo;Infection;innovation;Intravenous;Malignant - descriptor;Malignant neoplasm of brain;Malignant Neoplasms;manufacture;Modeling;Molecular;mouse model;Mus;Mutation;neurotropic;neurotropic virus;novel;novel therapeutics;Oncolytic;Oncolytic viruses;oncolytic Zika virus;Operative Surgical Procedures;Organ;Outcome;patient derived xenograft model;patient prognosis;Patient-Focused Outcomes;Patients;Phase;Population;Predisposition;Property;prospective;Radiation;radioresistant;Rat Cell Line;Rattus;repaired;Resistance;resistance mechanism;response;Route;Safety;Small Business Innovation Research Grant;standard of care;stem cells;synergism;temozolomide;Testing;Therapeutic;therapy resistant;Time;Tissues;Toxic effect;tumor;Tumor Immunity;tumor microenvironment;tumor-immune system interactions;United States;Validation;Viral;Virulent;Virus;Virus Replication;Work;Zika Virus;ZIKV infection

PROJECT_TITLE: Validation of a novel treatment for glioblastoma using oncolytic Zika virus


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Lung;Natural Products;Pneumonia;Pneumonia and Influenza

ORG_CITY: Salt Lake City

ORG_NAME: CURZA INC

ORG_STATE: UT

PHR: Project Narrative This project will lead to the development of the first new class of antibiotics in over 40 years to treat infections caused by Gram-negative bacteria, especially life-threatening multidrug-resistant pathogens. The antibiotics to be developed have a novel mechanism of action which should limit the occurrence of resistance and are not expected to encounter cross-resistance to other antibiotic classes. These antibiotics represent an exciting option to address the growing concern of antimicrobial resistance.

PI_NAMEs: TESTA, CHARLES  (contact)

PROJECT_TERMS: absorption;Acinetobacter baumannii;Acute;Address;analog;Animal Model;Anti-Bacterial Agents;Antibiotics;Antimicrobial Resistance;Bacteria;Bacterial Proteins;Binding;Binding Proteins;Biochemical;Biological;Biological Assay;candidate selection;Canis familiaris;Cells;Chemicals;Chemistry;Clinical;clinical candidate;Cyclic GMP;Cytochrome P450;cytotoxicity;Data;Development;Dose;Dose Fractionation;drug candidate;drug efficacy;Drug Kinetics;Engineering;Epithelium;Evaluation;Excretory function;Exhibits;experimental study;Frequencies;genotoxicity;Gram-Negative Bacteria;HepG2;improved;In Vitro;in vitro activity;in vivo;indexing;Infection;Klebsiella pneumoniae;Lead;lead candidate;lead optimization;lead series;Life;Link;Liquid substance;Liver Microsomes;Mammalian Cell;manufacture;Maximum Tolerated Dose;meetings;Metabolic;Metabolism;meter;Minimum Inhibitory Concentration measurement;Mitochondria;Modeling;Multi-Drug Resistance;multi-drug resistant pathogen;Mus;Mutation;Mycobacterium tuberculosis;natural product inspired;Natural Products;novel;novel antibiotic class;pathogen;Pharmaceutical Preparations;Pharmacodynamics;pharmacokinetics and pharmacodynamics;Pharmacologic Substance;Pharmacology;pharmacophore;Phase;Plasma;pneumonia model;Production;programs;Property;Protein Biosynthesis;Protein Isoforms;Pseudomonas aeruginosa;Rattus;receptor binding;Regimen;Resistance;resistant strain;response;Ribosomes;Safety;scale up;Septicemia;Series;Site;Small Business Innovation Research Grant;Structure;Testing;Time;Toxic effect;Toxicology;Urinary tract infection

PROJECT_TITLE: A new class of antibiotic to address Antimicrobial Resistance

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-F (12)]


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Bioengineering;Social Determinants of Health

ORG_CITY: ANDOVER

ORG_NAME: PHYSICAL SCIENCES, INC

PHR: Project Narrative Knowledge of real-time continuous measurement of benzene concentrations in outdoor rural and urban environments, workplaces, and industrial sites is needed for assessing accurately personal exposures, implementing potential exposure alert system, and identifying rapidly the emission sources for prompt mitigation measures. Therefore, cases of cancer linked to benzene would be reduced significantly.

PI_NAMEs: CHEN, SHIN-JUH  (contact)

PROGRAM_OFFICER_NAME: SHAUGHNESSY, DANIEL

PROJECT_TERMS: absorption;Air;Air Pollution;air sampling;Area;Benzene;Boston;Calibration;Cancer Etiology;Carcinogens;Cells;Cessation of life;commercialization;Consensus;cost;Country;Custom;Data;data acquisition;Data Analytics;design;Detection;detection limit;detection platform;detector;Electronics;Engineering;Environment;Environmental Exposure;Environmental Impact;Environmental Wind;Ethane;expectation;experience;Exposure to;field study;field survey;Gases;Gasoline;General Population;Goals;Health;Hour;Household;Human;Human body;improved;Indoor environment;Industrialization;instrument;Knowledge;Laboratories;Lasers;leukemia;Link;Location;Lung;Malignant Neoplasms;Manuals;Measurement;Measures;meter;Methane;Methods;Modality;Monitor;Municipalities;Natural Gas;Needs Assessment;operation;Optics;Ozone;Particulate;Performance;Phase;physical science;Positioning Attribute;premature;prevent;Process;Program Development;Protocols documentation;prototype;Publishing;quantum;Reaction Time;research and development;response;rural environment;sensor;Signal Transduction;simulation;Site;Source;Spectrum Analysis;Surveys;System;Technical Expertise;Technology;Temperature;Testing;Time;tool;urban setting;Walking;Workplace

PROJECT_TITLE: High-Sensitivity Benzene Detector for Environmental Field Surveys

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-S (12)]


ADMINISTERING_IC: VA

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: Veterans Affairs

ORG_CITY: WASHINGTON

ORG_NAME: U.S. DEPT/VETS AFFAIRS MEDICAL CENTER

ORG_STATE: DC

PHR: Project Narrative: The prevalence of kidney stones and associated clinical condition in the United States has risen for decades. The diagnosis, treatment, high recurrence, hospitalizations, surgery, and lost work time account for over 5 billion dollars in economic burden in the United States each year. Stone formation is also associated with increased rates of chronic kidney disease and hypertension which are not sufficiently explained by obesity, a risk factor in each of these conditions. The majority (80%) of these calcium stones are found to be calcium oxalate (CaOx), with variable amounts of calcium phosphate (CaP). The proposed validation research aims to develop a new level of understanding on the mechanisms of kidney stone formation using an innovative microfluidic platform towards advancing new clinical solutions for preventing or treating nephrolithiasis and other diseases relevant to extra-skeletal calcification.

PI_NAMEs: BANDYOPADHYAY, BIDHAN CHANDRA (contact)

PROJECT_TERMS: 3-Dimensional;Animal Testing;Apical;Apoptosis;Atherosclerosis;base;Basic Science;Biochemical;Biochemistry;Biological;biomineralization;Blood Vessels;calcification;Calcium;Calcium Oxalate;calcium phosphate;Cardiovascular Diseases;cell behavior;cell growth regulation;cell injury;Cells;cellular pathology;Characteristics;chemical release;Chronic Kidney Failure;Clinical;Complex;Crystal Formation;Crystallization;Cues;Data Set;Defect;Deposition;Devices;Diagnosis;Disease;Economic Burden;Engineering;Epithelial Cells;Epithelium;Excision;Fibrosis;Fluorescence;Genetic;Goals;Growth;high throughput screening;Hospitalization;Hypertension;Immune;Implant;improved;in silico;In Situ;In Vitro;in vivo;Inflammation;Inflammation Process;Inflammatory;inhibitor;innovation;insight;Intervention;Ions;Kidney;Kidney Calculi;Kidney Diseases;Kinetics;Life;Liquid substance;lost work time;macromolecule;Maps;Membrane;Methodology;Methods;Microfluidic Microchips;Microfluidics;Microscopic;Microscopy;microsystems;mineralization;Modeling;Molecular;multimodality;Nephrolithiasis;novel;Obesity;Operative Surgical Procedures;optical imaging;Optics;Organ;Oxidative Stress;Pathogenesis;Pathologic;Patients;Pattern;Perfusion;Pharmaceutical Preparations;pharmacologic;Phase;Physiological;Polarization Microscopy;Porosity;Prevalence;prevent;Process;programs;Reactive Oxygen Species;reconstruction;Recurrence;Regulatory Pathway;Research;research clinical testing;Risk Factors;Role;Sampling;shear stress;Signal Transduction;soft tissue;spatiotemporal;Structure;System;Testing;Time;Tissue Extracts;Tissue Model;Tissues;tool;Toxicology;Transmission Electron Microscopy;Tubular formation;two-dimensional;United States;Validation;Vascular calcification

PROJECT_TITLE: Engineered 3D microfluidic tubular device as multimodal, functional tissue model

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 NEPH-N (01)]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Atherosclerosis;Brain Disorders;Cardiovascular;Cerebrovascular;Dementia;Genetics;Heart Disease;Neurodegenerative;Neurosciences

ORG_CITY: CINCINNATI

ORG_DEPT: ANATOMY/CELL BIOLOGY

ORG_NAME: UNIVERSITY OF CINCINNATI

ORG_STATE: OH

PHR: Project Narrative The proposed research will shed light on the vascular effects of CCDC92, which would serve as the foundation for the potential therapeutic strategy for Alzheimer’s disease. Reducing neuroinflammation is expected to improve cognitive function and inhibit the development and progression of Alzheimer’s disease. Our study is anticipated to accelerate the discovery of fundamental mechanisms significantly, providing potential new therapeutic avenues for Alzheimer's disease.

PI_NAMEs: FAN, YANBO  (contact)

PROGRAM_OFFICER_NAME: PLAYFORD, MARTIN P

PROJECT_TERMS: abeta accumulation;abeta deposition;Ablation;Acceleration;Administrative Supplement;Affect;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease patient;American;Amyloid beta-Protein;Animal Model;APP-PS1;Astrocytes;Atherogenic Diet;Atherosclerosis;Attenuated;Autophagocytosis;Behavior;behavioral study;Biogenesis;Blood capillaries;Blood Vessels;brain tissue;Cardiovascular Diseases;Cell Communication;Cells;cerebrovascular;Cerebrovascular Circulation;Cerebrovascular system;Cerebrum;Cholesterol;Chronic;Circle of Willis;Code;cognitive function;Coiled-Coil Domain;Complex;Coronary heart disease;Coupled;cytokine;Data;density;Deposition;Development;Diet;Disease;Disease Progression;Exhibits;extracellular;Fatty acid glycerol esters;FDA approved;Female;Foundations;Functional disorder;Funding;gene regulatory network;Genes;Genetic study;Goals;Human;Human Genetics;human old age (65+);hydroxypropyl-beta-cyclodextrin;hypercholesterolemia;Impaired cognition;Impairment;improved;Inflammation;Inflammatory;Inflammatory Response;Insulin Resistance;insulin signaling;Intracranial Atherosclerotic Disease;Knock-in Mouse;Knock-out;Knockout Mice;Low Density Lipoprotein Receptor;LoxP-flanked allele;Magnetic Resonance Imaging;male;Measures;Memory Loss;Meta-Analysis;Microglia;morris water maze;mouse model;Mus;Neurodegenerative Disorders;Neurofibrillary Tangles;neuroinflammation;neuron loss;Neurons;neuropathology;Non-Insulin-Dependent Diabetes Mellitus;novel;novel therapeutics;overexpression;parent grant;parent project;Parents;Pathogenesis;Pathway interactions;Persons;Pharmacologic Substance;Phenotype;precision medicine;Regulatory Pathway;Research;Risk Factors;Role;Senile Plaques;single nucleus RNA-sequencing;single-cell RNA sequencing;Smooth Muscle Myocytes;Synapses;targeted treatment;tau-1;Testing;Therapeutic;Thioctic Acid;transcription factor;Transgenic Organisms;Variant;Vascular Smooth Muscle;Vascular Smooth Muscle Tissue

PROJECT_TITLE: CCDC92 and Cardiovascular Disease

STUDY_SECTION: AVI

STUDY_SECTION_NAME: Atherosclerosis and Vascular Inflammation Study Section[AVI]


ORG_CITY: ATLANTA

ORG_NAME: YOUNGHEARTVALVE LLC

PHR: Project Narrative: The goal of this project is to commercialize the Rejuvenate™ Valve, an advanced polymeric aortic valve that can be implanted using a catheter, avoiding the risks associated with open heart surgery and cardiopulmonary bypass. The plastic leaflets are precisely shaped for excellent blood flow, and engineered to maximize blood compatibility using a natural biomolecule, hyaluronan, which is present in all body tissues. SBIR Phase 2 funding will enable us to begin manufacturing scale-up, quality system and design control environments, and complete the chronic animal studies required to translate this technology to the clinic, and lead to a dramatic improvement in heart valve technology.

PI_NAMEs: TOMBA, TODD CHARLES (contact)

PROGRAM_OFFICER_NAME: EVANS, FRANK

PROJECT_TERMS: 3D Print;Acute;Address;Adolescent;Adopted;Animal Testing;Animals;Anticoagulation;Aorta;aortic valve;aortic valve replacement;Aortic Valve Stenosis;Architecture;arm;Automation;Bicuspid;bicuspid aortic valve;Bioprosthesis device;Blood;Blood flow;Blood Platelets;Blood Vessels;British Columbia;calcification;Cardiac Surgery procedures;Cardiopulmonary Bypass;Cardiovascular system;Catheters;Cessation of life;Chemicals;Chromium;Chronic;Clinic;Cobalt;Collaborations;commercialization;commercialization readiness;Computers;cost;density;design;design verification;Development;Employee;Engineering;Environment;Evaluation;experience;Extravasation;Farm;Feedback;Finite Element Analysis;first-in-human;flexibility;Fluoroscopy;Freezing;Funding;Future;Glycocalyx;Goals;Grant;Growth;Healthcare;heart valve replacement;Heart Valves;hemocompatibility;hemodynamics;Hospitals;Human;Hyaluronan;Image;Implant;improved;In Situ;in vivo;Incubated;Industry;Injury;innovation;Intervention;Laboratories;Lead;Leadership;Legal patent;Life;Longevity;manufacture;manufacturing process;manufacturing scale-up;Marketing;Mechanics;Medical Device;Medicine;Modeling;novel;Operative Surgical Procedures;particle;Patients;Performance;Pericardial body location;Phase;Polyethylenes;Polymers;Positioning Attribute;Preclinical Testing;prevent;Process;professor;programs;Pulsatile Flow;Rejuvenation;Research;Resistance;Risk;sample fixation;scale up;seal;Series;Shapes;Sheep;sheep model;Sinus;Small Business Innovation Research Grant;Societies;Stents;supply chain;Surgical sutures;Surgical Valves;Swelling;System;Technology;technology platform;Testing;Thrombosis;tissue fixing;Tissues;Translating;United States National Institutes of Health;Velocimetries

PROJECT_TITLE: SBIR Phase II: Novel Hyaluronan Enhanced Polymeric Trans-Catheter Aortic Valve

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-W (12)]


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Depression;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Networking and Information Technology R&D (NITRD);Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health;Women's Health Research

ORG_CITY: Arlington

ORG_NAME: ISA ASSOCIATES, INC.

ORG_STATE: VA

PHR: PROJECT NARRATIVE  The project aims to develop a mobile stress management intervention designed to reduce stress among Hispanic women. Because Hispanic women have access to and utilize smartphones at high rates, a theory- based, mobile stress management intervention is a highly accessible, scalable, and an effective approach to reduce negative health outcomes related to unmanaged stress. The proposed stress management intervention is designed for use in healthcare and clinic settings and community-based organizations that provide women’s and mental health services to Latina adults.

PI_NAMEs: RIOS, DEBRA  (contact)

PROGRAM_OFFICER_NAME: JOHNSON, JARRETT AINSWORTH

PROJECT_TERMS: 18 year old;Acculturation;Address;Adult;Affective;alcohol use disorder;base;Behavioral;behavioral health;Benchmarking;biological adaptation to stress;Breast Cancer survivor;Cardiovascular Diseases;cardiovascular disorder risk;care providers;Cellular Phone;Chronic stress;Clinic;Cognitive;community based care;community organizations;Comprehension;coping;cost effective;cultural values;Data;design;Development;Diabetes Mellitus;diabetes risk;Discrimination;Disparity;Education;Effectiveness;effectiveness evaluation;Effectiveness of Interventions;Ethnic Origin;experience;Exposure to;Face;fasting glucose;Federally Qualified Health Center;Feedback;follow-up;Fostering;Gender;Glycosylated hemoglobin A;handheld mobile device;Health;Health behavior;health care quality;Healthcare;Hispanic;Hispanic Populations;Hispanic Women;Hour;Income;Internet;Intervention;Knowledge;Language;Latina;Latina Population;Latinx;Latinx population;Learning;Life Experience;life span;Link;Lived experience;Major Depressive Disorder;male;Malignant Neoplasms;Marketing;Measures;member;men;Mental Depression;Mental Health;Mental Health Services;mHealth;mhealth interventions;mindfulness;mindfulness meditation;Minority Groups;Modeling;Morbidity - disease rate;mortality;negative affect;Online Systems;Outcome;Participant;Pattern;perceived stress;Personal Satisfaction;Phase;physical conditioning;Physiological;poor health outcome;Population;prevent;Price;Process;programs;prototype;Psyche structure;psychologic;psychological outcomes;Public Health;Race;Randomized;Reduce health disparities;Reporting;Research;response;Risk;Risk Factors;Role;Services;skills;Social Identification;Social support;Socioeconomic Status;Source;Spanish;Spanish/English;stem;Stress;stress management;stress reduction;stressor;success;support tools;Techniques;theories;therapy design;tool;Training;Transact;Translations;Underserved Population;uptake;web app;web page;Woman

PROJECT_TITLE: Quédate Tranquila: A Mobile, Web-based Stress Management Intervention for Hispanic Women

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-D (10)]


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Lead Poisoning;Pediatric;Social Determinants of Health

ORG_CITY: EVANSTON

ORG_NAME: SKYWAY BIOSCIENCES

ORG_STATE: IL

PHR: PROJECT NARRATIVE The CDC has declared that no level of lead (Pb) exposure is safe for children, yet the vast majority of newborns, infants, and children in the US are not tested, due in part to the technical and logistical challenges of obtaining venous blood in early life. In this Phase I STTR proposal, we will address this challenge by optimizing and validating a Pb-free blood collection device that can accurately quantify low blood lead levels in a single drop of heel or finger stick blood.

PI_NAMEs: AHUJA, PUNKAJ  (contact);FUNK, WILLIAM E

PROJECT_TERMS: 6 year old;Adoption;Adult;Behavior Disorders;behavioral health;Biological Assay;Biotechnology;Blood;Blood capillaries;blood lead;Blood specimen;Blood Volume;Body System;Brain;Breathing;Child;Child Development;Child Health;Childhood;Cognitive;Collection;commercialization;contaminated water;cost;Country;design;detection limit;Devices;Diagnostic tests;District of Columbia;Drops;Dryness;Dust;Eating;Environmental Risk Factor;fetal;Fingers;Food;Future;Geographic Factor;Heavy Metals;Heel;Housing;Human Development;Impairment;indexing;Individual;Infant;Ingestion;innovation;Intellectual functioning disability;Laboratories;Lead;lead contamination;lead exposure;Lead levels;Lead Poisoning;Legal patent;Life;manufacture;Maps;Marketing;Measures;Metals;Methods;minimally invasive;Neurologic;new technology;Newborn Infant;novel strategies;Paper;Parents;Phase;physical conditioning;point of care;Population;Procedures;Process;Proteins;prototype;Public Health;Recommendation;recruit;remediation;Reporting;Risk;Sampling;screening;Small Business Technology Transfer Research;sociodemographics;Spottings;Symptoms;Technology;Testing;Trace Elements;Tube;Validation;Venipunctures;Venous;volunteer;Whole Blood;World Health Organization

PROJECT_TITLE: Optimization and Validation of Minimally-Invasive and Low-Cost Blood Collection Device for Lead Testing


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Breast Cancer;Cancer;Women's Health Research

ORG_CITY: BROOKLYN

ORG_NAME: XYLYX BIO, INC.

PHR: NARRATIVE In this SBIR Fast Track project, Xylyx proposes to develop and commercialize a multi-organ metastatic breast cancer cell-based assay platform that helps scientists develop effective drugs for treating metastatic breast cancer, the second leading cause of death from cancer. Predictive models for testing metastatic breast cancer drugs are lacking, leaving a significant unmet need and market gap for a physiologically-relevant assay platform. The commercial product from this project will be an assay platform that accelerates therapeutic development for metastatic breast cancer, and empowers high-impact discoveries that will improve treatment options and outcomes for the millions of patients with metastatic disease.

PI_NAMEs: O'NEILL, JOHN DAVID (contact)

PROGRAM_OFFICER_NAME: LI, MELISSA WANLING

PROJECT_TERMS: 3-Dimensional;Acceleration;Address;Animal Model;Antineoplastic Agents;Antitumor Drug Screening Assays;Biochemical;Biological Assay;Biomanufacturing;Biopsy;bone;Breast Cancer Cell;breast cancer metastasis;Breast Cancer Model;Breast Cancer Patient;Breast Epithelial Cells;cancer diagnosis;Cause of Death;Cell Communication;Cell Line;cell motility;Cells;Cessation of life;Clinical;Coculture Techniques;Coenzyme A;commercialization;cost;Data;Data Set;Decision Making;Dependence;Development;Diagnosis;Disease;disease model;Disseminated Malignant Neoplasm;Documentation;drug development;drug market;Drug Screening;drug testing;effective therapy;empowerment;Engineering;Extracellular Matrix;Facility Controls;Fibroblasts;Gene Expression;Gene Expression Profiling;Genes;Goals;Histologic;Human;Human Engineering;human tissue;improved;In Vitro;in vitro Model;in vivo;Industry;International;Interview;Invaded;Knowledge;Legal patent;Liver;Lung;Malignant Bone Neoplasm;Malignant Breast Neoplasm;Malignant Neoplasms;mammary epithelium;Mammary Neoplasms;manufacture;manufacturing process;Manuscripts;Marketing;matrigel;Mechanics;metabolomics;Metastatic breast cancer;Metastatic Neoplasm to the Bone;Methods;Modeling;Molecular;Morphology;multiple omics;Neoplasm Metastasis;neoplastic cell;Organ;Organoids;Outcome;Paclitaxel;Paper;Patients;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phenotype;Physiological;Play;pre-clinical;predictive modeling;predictive test;product development;Property;Protein Secretion;Proteins;Proteomics;Protocols documentation;Publications;Publishing;quality assurance;Quality Control;Reagent;Reporting;Reproducibility;response;Risk;Risk Reduction;Rodent;Role;scale up;Scientist;Services;Small Business Innovation Research Grant;Specific qualifier value;Specificity;standard of care;Standardization;stem;success;supply chain;Tamoxifen;targeted agent;targeted treatment;technological innovation;Technology;Test Result;Testing;testing services;therapeutic development;Tissues;transcriptome sequencing;Trastuzumab;tumor growth;validation studies;verification and validation;Woman;Work

PROJECT_TITLE: Multi-organ metastatic breast cancer cell-based assay platform that models organotropic metastases using patient organoids in human tissue-derived ECMs to accelerate anti-metastatic drug development

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BBBT-F (10)]


NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Clinical Research;Heart Disease;Nutrition;Physical Activity

ORG_CITY: CHARLOTTESVILLE

ORG_NAME: BARRON ASSOCIATES, INC.

PHR: Project Narrative The proposed M3 system will address the current gap in the availability of an inexpensive, easy-to-use, and accurate system for measuring key ventilatory quantities in healthy adults and cardiac rehabilitation (CR) settings for tracking patients' physiological responses to exercise and optimizing their exercise prescriptions. It is well documented in the literature that the key limitations of the gold-standard cardiopulmonary exercise test (CPET) are directly related to the expertise required to perform the test and its associated costs (both equipment and personnel). Outside of CR applications, the proposed M3 system will also provide a transformative technology that will not only compete in existing markets, but will serve to create new markets (e.g., hospital, sports, health and wellness applications, etc.), which will further reduce its relatively low cost due to economies of scale.

PI_NAMEs: CLARK, BRIAN R;PARKER, B EUGENE (contact)

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TERMS: Acute;Adult;Aerobic;Aerobic Exercise;Air;Arizona;Atmosphere;barometric pressure;Basal metabolic rate;Beds;Bicycling;Bluetooth;Body Weight decreased;Breathing;Calibration;Carbon Dioxide;Cardiac health;Cardiac rehabilitation;Cardiopulmonary;cardiorespiratory fitness;Characteristics;Chronic;Clinical;Clip;Collaborations;Collection;commercialization;Computer software;Computers;Congestive Heart Failure;Coronary Arteriosclerosis;cost;Critical Illness;Data;Data Collection;Development;dietary;Dryness;Education;Energy Metabolism;Enteral Nutrition;Equipment;Exercise;exercise prescription;exercise regimen;Exercise stress test;Exercise Test;exercise training;Exhalation;Extravasation;Face;face mask;Facilities and Administrative Costs;fitness;Flowmeters;Flushing;Gases;Goals;Health;Hospitals;Human Resources;human subject;Humidity;improved;Indirect Calorimetry;Individual;Insurance;light weight;Literature;Lung;Marketing;Measurement;Measures;Memory;Metabolic;Nose;novel;operation;Outpatients;Oxygen;Oxygen Consumption;Parenteral Nutrition;Patient Monitoring;Patients;Performance;performance tests;Phase;Physiological;Physiology;Preparation;pressure;pressure sensor;prevent;Production;prognostic;programs;prototype;Ramp;Reaction;Reaction Time;rechargeable battery;Research;respiratory gas;response;Rest;Running;Schedule;sensor;Small Business Innovation Research Grant;Specific qualifier value;Sports;Stress;success;System;Tablet Computer;Tablets;Technology;Temperature;Testing;Time;Training;Translations;treadmill;Universities;Validation;Variant;ventilation;Virginia;voltage;Walking;Work

PROJECT_TITLE: A Novel, Low-Cost Mobile Metabolic Measurement (M3) System

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (11)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cardiovascular;Clinical Research;Heart Disease;Heart Disease - Coronary Heart Disease;Pediatric

ORG_CITY: BETHESDA

ORG_NAME: PERICOR, LLC

ORG_STATE: MD

PHR: Project Narrative We are proposing a novel tool and technique for safe, fluoro-free, pericardial access by using color imaging to directly visualize the heart with associated tissue layers and key cardiac structures such as the coronary arteries. We hypothesize that this technique is safer than the current standard of care because 1) these critical tissue layers are not visible with fluoroscopic imaging which leads to accidental ventricular perforation with pericardial bleeding, and 2) color imaging removes the need for fluoroscopy which has harmful ionizing radiation effects that are bad for the operator and patient, especially for the vulnerable pediatric population. We hope this tool provides an important solution for a safer standard of care for the thousands of patients that undergo a pericardial access procedure to deliver cardiac therapies to the epicardial surface of the heart such as epicardial ablation for ventricular tachycardias.

PI_NAMEs: BERUL, CHARLES I;KUMTHEKAR, ROHAN ;OPFERMANN, JUSTIN  (contact)

PROJECT_TERMS: Ablation;Accidents;Acute;Address;Adult;Angiography;Aorta;Biomedical Engineering;Carbon Dioxide;Cardiac;Cardiac ablation;cardiac resynchronization therapy;Cardiac Surgery procedures;Chest;Child;Childhood;Clinical;clinical practice;Color;Complication;Computer software;congenital heart abnormality;Coronary Angiography;Coronary artery;Coronary sinus structure;Custom;design;Devices;Diameter;digital;Echocardiography;Electric Countershock;Emergency Situation;Engineering;Enrollment;Ensure;epicardial mapping;experience;Fluoroscopy;Glass;Goals;Heart;heart imaging;heart visualization;Hemorrhage;Hemostatic function;high resolution imaging;Hospitals;Image;image guided;Imaging Techniques;implantation;improved;in vivo;Infant;Injury;innovation;Insufflation;Intervention;Interview;Intuition;Ionizing radiation;Lateral;lens;Lesion;Letters;Life;Light;Lighting;Measures;microsensor;multidisciplinary;Needles;Needlestick Injuries;next generation;novel;novel strategies;Operative Surgical Procedures;optical fiber;Optics;Patients;Pediatric Hospitals;Perforation;Pericardial body location;pericardial sac;Pericardiocentesis;Phase;Population;porcine model;procedure safety;Procedures;Puncture procedure;radiation effect;Radiofrequency Interstitial Ablation;Regulatory Pathway;Research;Research Personnel;Resolution;Safety;Severities;Site;skills;Skin;Small Business Technology Transfer Research;standard of care;Structure;success;Surface;Surgeon;System;Techniques;Time;Tissues;tool;Training;United States;usability;Venous;venous sinus;Ventricular;Ventricular Tachycardia;Visualization;Work

PROJECT_TITLE: PeriScope: A Novel Videoscope and Toolkit to Enable Fluoro-free Pericardial Access for Epicardial Ablation

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (13)]


ORG_NAME: NANOAFFIX SCIENCE, LLC

PHR: PROJECT NARRATIVE  This project aims to develop a handheld portable testing device for rapid point-of-use detection of per- and polyfluoroalkyl substances (PFAS) in water. PFAS accumulates in the environment because it does not breakdown quickly, and it has been shown to cause cancer and other health problems. PFAS is disseminated throughout the environment and consumed by humans through water systems. Current quantitative detection methods for PFAS are expensive laboratory tests and there is an unmet need for a portable, rapid, cost-effective point-of-use detector of PFAS in water.

PI_NAMEs: HILL, JAMES CURTIS (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TERMS: Address;Affect;Artificial Intelligence;Bacteria;Behavior;beta-Cyclodextrins;Binding;Biological;Calibration;Cancer Etiology;carcinogenicity;Carcinogens;Chemicals;Communities;Consumption;contaminated water;cost;cost effective;Coupled;Data Analyses;data communication;design;Detection;detection limit;detection method;detector;Development;Devices;digital;Disinfection;drinking water;Ecosystem;Electrodes;Electronics;Electrostatics;Engineering;Ensure;Environment;Equipment;equipment training;Exposure to;Fire - disasters;Goals;Gold;graphene;handheld equipment;Health;Heavy Metals;Human;Human Resources;Hydrophobic Interactions;Immobilization;Immune system;improved;invention;Ions;Label;Laboratories;Lead;Legal patent;Licensing;Liquid Chromatography;liquid chromatography mass spectrometry;Low Birth Weight Infant;Machine Learning;Malignant Neoplasms;manufacture;Mass Spectrum Analysis;Measurement;Measures;Mercury;meter;Methods;Modeling;Molecular Probes;nanomaterials;nanoparticle;nanosensors;novel;Nutrient;operation;Oxides;perfluorooctane sulfonate;perfluorooctanoic acid;Performance;Persons;Phase;Poison;Poly-fluoroalkyl substances;portability;Preparation;Property;Proteins;prototype;rapid detection;real time monitoring;Recommendation;Regulation;Research;response;Risk;Risk Management;Safety;Sampling;Science;Sensitivity and Specificity;sensor;Signal Transduction;Site;skills;Small Business Innovation Research Grant;Specificity;Spectrometry;Structure;substance use;Surface;System;tandem mass spectrometry;Technology;technology platform;Test Result;Testing;Textiles;thyroid disruption;Time;Toxic effect;Training;Transistors;two-dimensional;United States Environmental Protection Agency;Water;wireless

PROJECT_TITLE: Graphene-based Nanosensors for Rapid Detection of Low-concentration PFAS in Water


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Biotechnology;Brain Disorders;Cerebrovascular;Dementia;Nanotechnology;Natural Products;Neurodegenerative;Neurosciences

ORG_CITY: MT PLEASANT

ORG_NAME: SOMATOCEUTICS, LLC

ORG_STATE: SC

PHR: Project Narrative The goal of this project is to provide proof of principle that Somatoceutics, LLC’s SMC-101 nanotubes (NTs) are non-toxic, stable, and efficacious drug delivery devices capable of encapsulating galantamine (GAL) for targeting the blood brain barrier (BBB) and penetrate the CNS. As such, they will provide an advantage over currently available approaches for the treatment of Alzheimer’s disease (AD) and other dementias. Successful completion of the two proposed aims will result in NT preparations with safer, more effective activity profiles for delivering small molecule drugs and biologicals in AD. Overall, this Phase I project will enable us to optimize the size, stability, drug loading efficiency, and RGD-dependence of SMC-101 NTs and their ability to undergo transcytosis in vitro (AIM 1). In AIM 2 we will test the toxicity of SMC-101 NTs in C57Bl/6 mice and examine the ability of SMC-101 NTs to cross the BBB in mice and enhance CNS penetration of GAL over unencapsulated GAL. Successful completion of these in vitro and in vivo analyses will place Somatoceutics, LLC in a strong position for moving to a Phase II application and more rigorous animal testing prior to commercialization and human studies.

PI_NAMEs: ROSENZWEIG, STEVEN ALAN (contact)

PROJECT_TERMS: abeta accumulation;Address;Adverse effects;Affect;Affinity;Age;aging population;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease patient;Alzheimer's disease related dementia;Amyloid beta-Protein;Animal Testing;antagonist;Attenuated;Binding;biomaterial compatibility;Blood - brain barrier anatomy;blood-brain barrier crossing;blood-brain barrier penetration;C-terminal;C57BL/6 Mouse;Carbon;Carbon Nanotubes;Cells;cerebral atrophy;Chemicals;Chimeric Proteins;Cholinesterase Inhibitors;Clinical;Clinical Trials;Cognition;commercialization;compare effectiveness;Dementia;Dependence;Development;Devices;disulfide bond;donepezil;Doxorubicin;Drug Delivery Systems;Drug Targeting;Drug toxicity;Effectiveness;Encapsulated;Endothelial Cells;Endothelium;Exhibits;Extracellular Matrix Proteins;Future;Galantamine;Goals;Heparin Binding;Hippocampus;Human;hyperphosphorylated tau;IGFBP2 gene;improved;In Vitro;in vivo;in vivo evaluation;Incidence;Integrins;Kinetics;Length;lipophilicity;Liposomes;Mediating;Memantine;Memory Loss;Modeling;Monoclonal Antibodies;Movement;Mus;N-Methyl-D-Aspartate Receptors;Names;nanoformulation;nanoGold;nanomaterials;nanoparticle delivery;nanoparticle drug;Nanotechnology;Nanotubes;Neurodegenerative Disorders;Neurofibrillary Tangles;Neurons;novel;novel diagnostics;Oral;Patient Compliance;Patients;Penetration;peptide drug;Peptides;Persons;Pharmaceutical Preparations;Phase;Population;Positioning Attribute;Preparation;Procedures;Production;Property;Public Health;Research;RGD (sequence);rivastigmine;Safety;scale up;self assembly;Senile Plaques;Serum;small molecule;Specific qualifier value;Specificity;Standardization;Structure;System;tau Proteins;Technology;Therapeutic;Therapeutic Monoclonal Antibodies;therapeutically effective;tool;Toxic effect;Toxicity Tests;transcytosis;uptake

PROJECT_TITLE: Non-toxic CNS drug delivery across the BBB in Alzheimer's and other dementias


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Disability Research;Physical Injury - Accidents and Adverse Effects;Physical Rehabilitation;Regenerative Medicine;Rehabilitation

ORG_CITY: FARMINGTON

ORG_NAME: INPRINT BIO LLC

PHR: PROJECT NARRATIVE Volumetric muscle loss (VML) injuries, particularly those involving the lower extremities, are responsible for substantial morbidity, pain, and disability. In this study, InPrint Bio, LLC will test the biocompatibility and bioactivity of its colloidal hydrogel product called MuscleInk and the version carrying a biological factor, MuscleInk+, in vitro and in rodent and porcine models. This product offers patients with muscle loss an adhesive macroporous scaffold for tissue regeneration and functional recovery.

PI_NAMEs: BARNUM, LINDSAY C (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: 3D Print;Address;Adhesions;Adhesives;Affect;Animal Model;Arginine;Biocompatible Materials;bioink;Biological;Biological Factors;Biological Process;biomaterial compatibility;Blood Vessels;Carbon Dioxide;cell motility;Cells;Clinical;Combined Modality Therapy;Complex;cost;crosslink;Data;Defect;density;design;differentiation in vitro;disability;Dislocations;Effectiveness;Engineering;Excision;Extracellular Matrix;Fibrosis;Filler;Fostering;Gelatin;Goals;Grant;Growth;Growth Factor;Histologic;Hospitals;Hydrogels;Hypertrophy;IGF1 gene;implantation;improved;improved outcome;In Situ;In Vitro;in vivo;Injury;Ink;Insulin-Like Growth Factor I;Intervention;Lead;Lifelong disability;Limb structure;Longevity;Lower Extremity;Measurement;mechanical properties;Metabolic;Methods;Morbidity - disease rate;Motion;mouse model;Muscle;muscle form;Muscle function;muscle hypertrophy;muscle regeneration;muscle strength;Muscular Atrophy;musculoskeletal injury;myogenesis;Natural regeneration;neural;novel strategies;Operative Surgical Procedures;Orthopedic Surgery;Pain;Patients;permissiveness;Phase;Physical assessment;physical property;Plastic Surgical Procedures;porcine model;Porosity;Postoperative Period;pre-clinical;Pre-Clinical Model;prevent;Printing;Procedures;Process;Property;Recovery;Recovery of Function;regenerative;Regulatory Pathway;Rehabilitation therapy;restoration;Risk;Rodent;Rodent Model;Running;scaffold;Secondary to;Site;Skeletal Muscle;Small Business Innovation Research Grant;Speed;standard of care;Sterilization;success;surgical service;Surgical sutures;Technology;Testing;Time;Tissue Engineering;tissue regeneration;tissue support frame;Tissues;Translations;trauma surgery;Traumatic injury;tumor;Vascularization;volumetric muscle loss;Work

PROJECT_TITLE: MuscleInk: A multifunctional colloidal scaffold for the treatment of muscle loss