Abstract
Cell therapy holds promise in addressing a number of unmet medical needs but despite its considerable impetus, faces numerous challenges including support for translational research in this area. Here, we examine the challenges confronting cell therapy research including the limited funding available for translational research partly due to the uncompetitive nature of required validation studies in cell therapy that of necessity are not hypothesis-driven. Other issues include lack of standardization of definitions of cell products, uncertainty regarding optimum preclinical animal models, duplication of efforts to secure regulatory approval and a lack of uniformity of nomenclature for some cell products. Nonetheless, several initiatives to address all of these issues are underway.
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References
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22(2): 151–185
DiMasi JA, Hansen RW, Grabowski HG, Lasagna L. Cost of innovation in the pharmaceutical industry. J Health Econ 1991; 10(2): 107–142
Williams DA, Keating A. Enhancing research in regenerative medicine. Blood 2010; 116(6): 866–867
Group NW. Enhancing Translational Research and Early Phase Trials for Cellular Therapy. Keating AWGC, Editor. 2008. Bethesday, Maryland
ICH. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6), in Safety Guidelines. 1997
ICH. Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6R1), in Safety Guidelines. 2009
FDA. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products. 2009
FDA. Guidance for Industry: Cellular Therapy for Cardiac Disease. 2010
FDA. Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. 2007
EMEA. Reflection paper on stem cell-based medicinal products. Therapies CfA, Editor. 2010
Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006; 8(4): 315–317
Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A. Clarification of the nomenclature for MSC: the International Society for Cellular Therapy position statement. Cytotherapy 2005; 7(5): 393–395
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Viswanathan, S., Keating, A. Overcoming the challenges of conducting translational research in cell therapy. Front. Med. 5, 333–335 (2011). https://doi.org/10.1007/s11684-011-0166-2
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DOI: https://doi.org/10.1007/s11684-011-0166-2