Cell Manipulation and Engineering — State of the Art and Future Developments

  • S. J. Noga
Conference paper
Part of the Developments in Hematology and Immunology book series (DIHI, volume 38)


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 [1]. 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 [2]. 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.


Peripheral Blood Stem Cell Chronic GvHD Embryonic Stem Cell Research Bone Marrow Graft Current Good Manufacturing Practice 
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Copyright information

© Springer Science+Business Media Dordrecht 2003

Authors and Affiliations

  • S. J. Noga
    • 1
    • 2
  1. 1.Oncology and PathologyThe Johns Hopkins UniversityBaltimoreUSA
  2. 2.Hematology and Medical Oncology, Alvin & Lois Lapidus Cancer InstituteSinai Hospital of BaltimoreBaltimoreUSA

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