title: Topical delivery of cultured stem cells to human non-healing wounds: GMP facility development in an academic setting and FDA requirements for an IND and human testing.
abstract: With increasing emphasis on translational research, the need for appropriate regulatory oversight and approval has become essential. The requirements of the Food and Drug Administration (FDA) for Investigational New Drug (IND) exemption in studies that are investigator-initiated have become increasingly stringent. Moreover, academic institutions have not had substantial experience in establishing Good Manufacturing Practice (GMP) facilities required for manipulating human cells in vitro and for chemical or biochemical manufacturing. GMP regulations are established by the FDA under the authority of the Federal Food, Drug and Cosmetic Act. In this report, the authors outline the general strategy and some critical steps that an investigator and the institution may find helpful in developing a GMP facility, especially in an academic center. Also, more specifically and as proof of principle, we describe our approach to culturing autologous bone marrow-derived human mesenchymal stem cells (MSCs) and delivering them to non healing wounds. The lessons learned in this often lengthy and challenging process may be helpful to other academic institutions and investigators embarking on manipulating and delivering viable cells for human experimentation.
authors.forename: Tatyana
authors.initials: T
authors.lastname: Yufit
authors.forename: Polly
authors.initials: P
authors.lastname: Carson
authors.affiliation: Department of Dermatology and Skin Surgery, Roger Williams Medical Center, 50 Maude Street, Providence Rhode Island 02908, USA. vfalanga@bu.edu.
authors.forename: Vincent
authors.initials: V
authors.lastname: Falanga
mesh_terms: D000046:Academic Medical Centers; D000287:Administration, Topical; D002478:Cells, Cultured; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D006801:Humans; D017387:Investigational New Drug Application; D045164:Mesenchymal Stem Cell Transplantation; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D014945:Wound Healing