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Stem Cell Therapies Walk A Risky Regulatory Road

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As the most advanced stem cell therapies, known collectively these days as "regenerative medicine," edge into the clinic, much about the field remains unresolved – including basic regulatory questions and whether the therapies, which hope to restore circulation to ischemic tissue or function to damaged nerves, for example, will even work in humans.

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