title: A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease.
abstract: The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252).
authors.affiliation: Departamento de Ciências Biológicas, Universidade Estadual Paulista - Unesp - Assis, SP, Brasil. Electronic address: jtrpaes@yahoo.com.br.
authors.forename: J T
authors.initials: JT
authors.lastname: Ribeiro-Paes
authors.affiliation: Programa de Pós-Graduação Interunidades em Biotecnologia: USP - Instituto Butantan - IPT - São Paulo, SP, Brasil.
authors.forename: T
authors.initials: T
authors.lastname: Stessuk
authors.affiliation: Programa de Pós-Graduação Interunidades em Biotecnologia: USP - Instituto Butantan - IPT - São Paulo, SP, Brasil.
authors.forename: M
authors.initials: M
authors.lastname: Marcelino
authors.affiliation: Pós-Graduação em Genética: Universidade de São Paulo (USP) - Ribeirão Preto, SP, Brasil.
authors.forename: C
authors.initials: C
authors.lastname: Faria
authors.affiliation: Faculdades Integradas Padre Albino, Catanduva, SP, Brasil.
authors.forename: T
authors.initials: T
authors.lastname: Marinelli
authors.affiliation: Faculdades Integradas Padre Albino, Catanduva, SP, Brasil.
authors.forename: M J
authors.initials: MJ
authors.lastname: Ribeiro-Paes
mesh_terms: D016026:Bone Marrow Transplantation; D001938:Brazil; D064987:Cell- and Tissue-Based Therapy; D002985:Clinical Protocols; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000601:surgery*; D011656:Pulmonary Emphysema; D033581:Stem Cell Transplantation
keywords: Cell therapy; Chronic obstructive pulmonary disease; Células‐tronco; Doença pulmonar obstrutiva crônica; Enfisema pulmonar; Pulmonary emphysema; Stem cells; Terapia celular