Innate Healthcare Institute
FDA's Center for Biologics Evaluation and Research issued a warning letter to Innate Healthcare Institute (Scottsdale, AZ) and its founder Travis Whitney, NMD, for marketing unapproved umbilical cord mesenchymal stem cells (UC-MSCs) and exosomes as treatments for autism, osteoarthritis, COPD, heart disease, and numerous other conditions without a valid Biologics License Application (BLA). The agency found the UC-MSC product fails the minimal manipulation and homologous-use criteria under 21 CFR 1271.10(a), making it an unapproved biological drug subject to premarket review. The product was also deemed misbranded under FD&C Act section 502(f)(1) for lacking adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.
Flagged claims (5)
Stem cell therapy for autism can lead to improvement in cognitive ability, behaviors, and sociability.
Stem cell therapy has really helped our son with his autism
Stem cell therapy with human umbilical cord tissue derived mesenchymal stem cells (UC-MSCs) corrects the inflammatory process by modulating the immune system from a pro-inflammatory attacking state to an anti-inflammatory healthy state. They also have the ability to regenerate damage done from the autoimmune attack. Stem cells do this by secreting healing activators such as growth factors, cytokines, and exosomes to the surrounding environment.
At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating Autism at its root.
Regenerative cell medicine has the potential to help with many conditions such as pain due to osteoarthritis, tendinopathy/tendonitis, degenerative disc disease, herniated discs, neuropathy, fractures, muscle injuries, ligament and tendon injuries, COPD, peripheral neuropathy, sexual dysfunction, autoimmune conditions, heart disease, and many more.
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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