Description of Collaborative Activity: |
The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are organizing a series of workshops that will engage the broader research community regarding requirements necessary for translation of pluripotent stem cell-derived products into the clinic. The first workshop, held March 2011, focused on establishment of stem cell lines and banks, covering safety and regulatory issues related to how the original cell line derivation is done in the case of embryonic stem cells, and how the cells are reprogrammed in the case of iPS cells. The second workshop, held July 10-11, 2012, focused on preclinical safety and proof of concept testing, including, among other topics, clinical relevance of the animal models, selection of cell dose levels, impact of host microenvironment, and cell fate post-administration. A third, and final, workshop is expected to focus on clinical trial design including safety monitoring, immunogenicity, immunosuppressant use and immune monitoring. |
NIH Participating Institutes/Centers/Office of the Director: |
NHLBI, NIDCR, NINDS, OD/DPCPSI |
