Cell Manipulation and Engineering — State of the Art and Future Developments
Within the last 5 years, the new field of somatic cell therapy (SCRx) has gone through exponential growth. This term was coined by the U.S.Food and Drug Administration (FDA) in guidance documents to encompass all materials of cellular or tissue origin used for therapeutic purposes . This included autologous, allogeneic and xenogeneic materials. Initially, human bone marrow was one of the only products other than blood that was processed or manipulated . New sources of stem cells capable of more rapid engraftment with fewer side effects soon followed. During this time period, various regulatory agencies began focusing on these new products, with the growth of both commercial and academic cell processing facilities. Agencies such as the FDA developed practice guidelines for processing these products. When the initial set of guidelines were proposed, it seemed logical that guidelines used for current good manufacturing practice (cGMP) be applied. With the advent of embryonic stem cell research and the literal explosion in new cellular tissues and components, the cGMP format became nearly unobtainable by most academic centers due to cost, physical requirements and regulatory/administrative issues. Now, most researchers hope to process under more generic, good tissue practice (GTP) standards, but even these are quite restrictive.
KeywordsPeripheral Blood Stem Cell Chronic GvHD Embryonic Stem Cell Research Bone Marrow Graft Current Good Manufacturing Practice
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- 1.FDA Guidelines to Industry. Somatic Cell therapy, 1998.Google Scholar
- 3.Donnenberg AD. T-cell depletion and allograft engineering. In: Law P, editor. Hematopoietic stem cell therapy. 1st ed. New York: Churchill Livingstone; 2000. pp. 335–44.Google Scholar
- 10.Current good manufacturing practice guidelines, Code of Federal Regulations. 2001:21210–211.Google Scholar
- 11.Burger S. Former Laboratory Director, Univ Minn cGMP cell processing facility. Personal communication, September, 2002.Google Scholar
- 12.Law P. Cell Harvest and Purification Technology — State of the Art and Future Developments. In: Smitibinga CTh and de Leij L, eds. Cellular Enginering and Cellular Therapies. Proc. 27th Sanquin Intern. Symp. on Blood Transfusion. Kluwer Academic Publ. Dordrecht, London, Boston 2003 :pp.Google Scholar