Dynamic Stem Cell Therapy
FDA's Center for Biologics Evaluation and Research issued a warning letter to Dynamic Stem Cell Therapy (Henderson, NV), directed to Medical Director Dale Carrison, D.O., for marketing an unapproved, unlicensed umbilical cord-derived stem cell product and exosomes via stemcellpowernow.com. The products were found to be unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act, and the stem cell product was deemed misbranded because it lacked adequate directions for use. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.
Flagged claims (2)
Anti-aging isn't the only amazing thing stem cell therapy can do--it has also been shown to improve various conditions resulting from injuries, like knee pain, spinal cord injury, joint pain, cardiovascular disease, and arthritis.
There are a number of different types of sports injuries that can be treated with stem cells, including: o Knee injuries such as ligament tears and cartilage damage o Shoulder injuries such as rotator cuff tears and bursitis o Ankle and foot injuries such as ankle sprains and Achilles tendon ruptures o Hip injuries such as hip labral tears and arthritis o Muscle strains and tears
Required actions (2)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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