FDA’s Adult Stem Cell Research

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Scientists who are part of the Food and Drug Administration’s MSC Consortium, are studying adult mesenchymal stem cells (MSCs) that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

According to the FDA, the investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

A consumer update from FDA quotes Carolyn A. Wilson, Ph.D., associate director for research at the center, as saying, “This research aims to facilitate development of this important class of innovative medical products. It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

Visit FDA’s Consumer Updates page for more information on adult sem cells and regenerative medicine.