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U.S. Department of Health and Human Services


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January 30: Is there any indication that FDA will stop regulating my cells? I cannot afford to travel great distances to obtain stem cells treatment for my chronic obstructive pulmonary disease. If stem cells are deemed a drug when will FDA allow clinical trials?

CDER Director's Mailbag

The regulation of stem cells or cell therapy in general, does not fall under my center; that’s regulated by the Center for Biologics Evaluation and Research (CBER) in FDA.  I will refer you question to CBER. Perhaps they can give you a more complete response to your particular question.

Stem-cell therapies offer the potential to treat diseases or conditions for which few treatments exist. Many stem-cell products have been reviewed by FDA for use in investigational studies.

I would caution consumers to make sure that any stem-cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA. The hope that patients have for cures not yet available can leave them vulnerable to unscrupulous providers of stem-cell treatments that are illegal and potentially harmful.