Can studies with human embryonic stem cells be included in the proposed protocols for Clinical center applications?
Research using cells lines on the NIH Human Embryonic Stem Cell Registry [http://stemcells.nih.gov/registry/index.asp] are eligible for federal funding. For use in a clinical study, a human embryonic stem cell line from this Registry would need to be qualified for this use by a series of preclinical studies that would be reviewed by the FDA. Investigators considering the use of these cell lines are encouraged to contact the FDA’s Center for Biologics Evaluation and Research (CBER) regarding the regulation of cellular therapy products.
Related Questions
- Can studies with human embryonic stem cells be included in the proposed protocols for Clinical center applications?
- Are clinical projects proposed by one Specialized Center implemented at the other Specialized Centers? Can they be?
- Can studies with human stem cells other than human embryonic stem cells be included in a Specialized Center?
