FDA Stem Cell Therapy Regulation: the Framework

Dina Gould Halme and David A. Kessler wrote an article, called FDA Regulation of Stem-Cell–Based Therapies in The New England Journal of Medicine. The key concerns are:

fdai., Stem-cell–based products as therapeutic agents are or could be: biologic products, drugs, devices, xenotransplantation products, human cells, tissues, and cellular and tissue-based products. Human cells, tissues, and cellular and tissue-based products is defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”

ii., Donor’s risk of transmitting infectious or genetic diseases

iii., Contamination or damage risk of the cell or tissue processing: expansion or differentiation of the cells are minimal manipulations, nonhuman fetal calf serum as possible prion source, anymal feeder cells, karyotypic =genetic stability through passages,

iv., Cell types: purity, potency, characterization, the expression pattern of identifying markers

v. In vivo safety and efficacy: experiments in animal models, tumorigenicity

vi., Stem-cell–based products and gene therapy


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