What the Heck is a Regenerative Medicine Therapy?

My favorite working definition for regenerative medicine is any medical intervention that is intended to repair, replace, restore or regenerate (the 4 R’s) the cellular, tissue or organ systems in the human body. As described by one of my former FDA colleagues, Dr. Steven Bauer, cellular therapies represent one branch of regenerative medicine that on their own can fulfill the 4 R’s. However, it is clear that many other medical technologies will contribute to the field of regenerative medicine. See my post on how the FDA views the world of regenerative medicine.

In fact, a few years back, the FDA’s Office of Cellular, Tissue and Gene Therapies (OCTGT) presented its views on the potential for cell therapy, gene therapy, human tissues or tissue engineering (biologic-device combination products) to be important medical counter-measures in the event of biological, radiological or chemical incident. The presentation is still relevant today, since it provides insights on how the FDA views the emerging field of regenerative medicine.

Technorati : FDA, cell therapy, gene therapy, regenerative medicine, tissue engineering

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