Pluripotent stem cells in translation: A Food and Drug Administration-National Institutes of Health collaboration

Stem Cells Translational Medicine

Volumn 2, Issue 7, 2013, Pages 483-487

  Kleitman, Naomi ^a   Rao, Mahendra S ^b   Owens, David F ^a  

^a NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Clinical translation; Clinical trials; Pluripotent stem cells; Stem cells

Indexed keywords

ARTICLE; FOOD AND DRUG ADMINISTRATION; HUMAN; NATIONAL HEALTH ORGANIZATION; NONHUMAN; PLURIPOTENT STEM CELL; STEM CELL TRANSPLANTATION; TRANSLATIONAL RESEARCH;

EID: 84879697913     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2013-0042     Document Type: Article

References (7)

1. Ho P-J, Yen M-L, Yet S-F et al. Current applications of human pluripotent stem cells: Possibilities and challenges. Cell Transplantation 2012;21:801-814.
2. Hamburg MA. Advancing regulatory science. Science 2011;331:987.
3. Collins FS. Reengineering translational science: The time is right. Sci Transl Med 2011;3: 90cm17.
4. Carpenter MK, Frey-Vasconcells J, Rao MS. Developing safe therapies from human pluripotent stem cells. Nat Biotechnol 2009;27:606-613.
5. Fink DW Jr. FDA regulation of stem cellbased products. Science 2009;324:1662-1663.
6. Aboody K, Capela A, Niazi N et al. Translating stem cell studies to the clinic for CNS repair: current state of the art and the need for a Rosetta Stone. Neuron 2011;70:597-613.
7. Au P, Hursh DA, Lim A et al. FDA oversight of cell therapy clinical trials. Sci Transl Med 2012;4:149fs31.