title: Regulatory aspects of small molecule drugs for heart regeneration.
abstract: Even though recent discoveries prove the existence of cardiac progenitor cells, internal regenerative capacity of the heart is minimal. As cardiovascular disease is the leading cause of deaths in the United States, a number of approaches are being used to develop treatments for heart repair and regeneration. Small molecule drugs are of particular interest as they are suited for oral administration and can be chemically synthesized. However, the regulatory process for the development of new treatment modalities is protracted, complex and expensive. One of the hurdles to development of appropriate therapies is the need for predictive preclinical models. The use of patient-derived cardiomyocytes from iPSC cells represents a novel tool for this purpose. Among other concepts for induction of heart regeneration, the most advanced is the combination of DPP-IV inhibitors with stem cell mobilizers. This review will focus on regulatory aspects as well as preclinical hurdles of development of new treatments for heart regeneration.
authors.affiliation: Titus Family Department of Clinical Pharmacy and Pharmacoeconomics and Policy, School of Pharmacy, University of Southern California, 1985 Zonal Avenue, Los Angeles, CA 90089, United States. Electronic address: krodgers@pharmacy.usc.edu.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Rodgers
authors.affiliation: Titus Family Department of Clinical Pharmacy and Pharmacoeconomics and Policy, School of Pharmacy, University of Southern California, 1985 Zonal Avenue, Los Angeles, CA 90089, United States.
authors.forename: Anna
authors.initials: A
authors.lastname: Papinska
authors.affiliation: Miltenyi Biotec, Inc., 2303 Lindbergh Street, Auburn, CA 95602, United States.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Mordwinkin
mesh_terms: D000818:Animals; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods; D004353:Drug Evaluation, Preclinical; D033161:Government Regulation; D006321:Heart / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000166:cytology / Q000187:drug effects; D032383:Myocytes, Cardiac / Q000166:cytology / Q000187:drug effects; D012038:Regeneration; D054852:Small Molecule Libraries / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054852:Small Molecule Libraries
keywords: Angiotensin (1-7) (PubChem CID: 123805); Cardiac; Cardionogen-2 (PubChem CID: 76849247); ICG-001 (PubChem CID: 11238147); Isx-1 (PubChem CID: 19582717); Lenograstim (PubChem CID: 17397400); ONO-1301 (PubChem CID: 9576846); Prostaglandin E2 (PubChem CID: 5280360); Pyrvinium (PubChem CID: 5281035); Regeneration; Regulatory; Sitagliptin (PubChem CID: 4369359); Small molecule; iPSC generated cardiomyocytes