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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)

Abstract

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.

Keywords

Peripheral Blood Stem Cell Chronic GvHD Embryonic Stem Cell Research Bone Marrow Graft Current Good Manufacturing Practice 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    FDA Guidelines to Industry. Somatic Cell therapy, 1998.Google Scholar
  2. 2.
    Noga, SJ. Graft Engineering, J Hematotherapy 1992;1:1–11.CrossRefGoogle Scholar
  3. 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
  4. 4.
    Rowley SD, Davis JM, Piantadosi S, Jones RJ, Yeager AM, Santos GW. Density-gradient separation of autologous bone marrow grafts before ex vivo purging with 4-hydroperoxycyclophosphamide. Bone Marrow Transplant 1990;6:321–27.PubMedGoogle Scholar
  5. 5.
    Noga, SJ. Graft Engineering, Sem Oncology 1999;15:124–28.CrossRefGoogle Scholar
  6. 6.
    Odonnell, PV, Jones RJ, Vogelsang GB, et al. CD34+ Stem cell augmentation of elutriated, allogeneic bone marrow grafts: Results of a Phase II Clinical Trial of engraftment and Graft-vs-Host Disease prophylaxis in high-risk malignancies. Bone Marrow Transplant 1998;22:947–55.CrossRefGoogle Scholar
  7. 7.
    Bensinger WI, Buckner CD, Shannon-Dorcy K, et al. Transplantation of allogeneic CD34+ peripheral blood stem cells in patients with advanced malignancy. Blood 1996;88:4132–38.PubMedGoogle Scholar
  8. 8.
    Cutler C, Giri S, Jeyapalan S, Paniagua D. Viswanathan A, Antin JH. Acute and chronic Graft-versus-Host Disease after allogeneic peripheral blood stem cell and bone marrow transplantation: A meta-analysis. J Clin Oncol 2001;19:3685–91.PubMedGoogle Scholar
  9. 9.
    Odonnell PV, Myers B, Edwards J, Loper K, Rhubard P, Noga SJ. CD34 Selection using three immunoselection devices: Comparison of Tcell depleted allografts. Cytotherapy 2001;3:483–88.CrossRefGoogle Scholar
  10. 10.
    Current good manufacturing practice guidelines, Code of Federal Regulations. 2001:21210–211.Google Scholar
  11. 11.
    Burger S. Former Laboratory Director, Univ Minn cGMP cell processing facility. Personal communication, September, 2002.Google Scholar
  12. 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

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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