Medicine Clinical Trials


FDA and Regenerative Medicine

Legislation and Regulation of Stem Cell therapies

• Stem cell and platelet therapies have been used for nearly 30 years. The public recently became aware of these innovative treatments within the past few years as professional athletes began using them to heal sports injuries where treatment options were limited following failure to respond to more conservative therapy.

• Currently, the FDA is conducting hundreds of clinical studies that investigate the utility of regenerative therapies on various musculoskeletal, ophthalmic, cardiovascular, and neurologic disorders. As each innovative approach receives FDA approval, including new uses for PRP and stem cells, we plan to add it to our current panel of Regenerative Medicine therapies.

• The FDA does not sanction or forbid the use of adult stem cell therapies; it just hasn’t yet approved them for routine clinical use. They have released certain guidelines that recommend how stem cells should be obtained and what degree of manipulation is acceptable without requiring a new therapeutic, biologic, or drug application (PHSA – Section 361). 

• The US Food and Drug Administration (FDA) has approved stem cell treatments primarily for use in treating Leukemia and immune deficiency syndromes. It has also approved them for compassionate care when immediate intervention is required to save a life and with patients enrolled in clinical trials. The FDA has not approved adult or amniotic membrane stem cells for routine clinical use. However, physicians may use stem-cell therapies “off label” as long as they use sound professional judgment, obtain proper consent, and maintain complete patient records.

• However, naturally occurring products such as bone marrow concentrate (BMC) and amniotic membrane extract may be used after appropriate patient consent about the investigational nature of the products since these contain stem cells as natural un-altered elements. This requirement ensures patient safety but still gives Texas physicians some latitude in their ability to offer life-changing therapies to those suffering from chronic pain or other debilitating conditions.If you are considering any Regenerative Medicine treatment for a musculoskeletal disorder, please contact us. There are several clinics, especially outside the United States, performing FDA “non-compliant” procedures that are controversial, unethical, and potentially dangerous. The FDA has issued several warnings about “medical tourism”, seeking unproven therapies abroad that may be deemed illegal in this country. We would welcome the opportunity to counsel you on the potential benefit and safety of these therapies.