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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front Med    2011, Vol. 5 Issue (4) : 333-335     DOI: 10.1007/s11684-011-0166-2
Overcoming the challenges of conducting translational research in cell therapy
Sowmya Viswanathan1(), Armand Keating1,2
1. Cell Therapy Program, Princess Margaret Hospital, University Health Network, Toronto, ON, M5G 2M9, Canada; 2. Division of Hematology, Department of Medicine, University of Toronto,Toronto, ON, M5G 2M9, Canada
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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.

Keywords stem cells      clinical trials      funding      animal models      standardization      common definitions     
Corresponding Authors: Viswanathan Sowmya,   
Issue Date: 05 December 2011
URL:     OR
1 DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22(2): 151-185
doi: 10.1016/S0167-6296(02)00126-1 pmid:12606142
2 DiMasi JA, Hansen RW, Grabowski HG, Lasagna L. Cost of innovation in the pharmaceutical industry. J Health Econ 1991; 10(2): 107-142
doi: 10.1016/0167-6296(91)90001-4 pmid:10113009
3 Williams DA, Keating A. Enhancing research in regenerative medicine. Blood 2010; 116(6): 866-867
doi: 10.1182/blood-2010-05-282723 pmid:20705767
4 Group NW. Enhancing Translational Research and Early Phase Trials for Cellular Therapy. Keating AWGC, Editor . 2008. Bethesday, Maryland
5 ICH. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6), in Safety Guidelines. 1997
6 ICH. Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6R1), in Safety Guidelines. 2009
7 FDA.Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products. 2009
8 FDA. Guidance for Industry: Cellular Therapy for Cardiac Disease. 2010
9 FDA. Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. 2007
10 EMEA. Reflection paper on stem cell-based medicinal products. Therapies CfA, Editor . 2010
11 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
doi: 10.1080/14653240600855905 pmid:16923606
12 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
doi: 10.1080/14653240500319234 pmid:16236628
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