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.
Keywords: Food and Drug Administration (FDA), Good Manufacturing Practice (GMP), Investigational New Drug (IND),
Mesenchymal Stem Cells (MSCs), Quality Assurance (QA), Quality Control (QC).
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