Mother Stem Institute, Corp.
FDA's Center for Biologics Evaluation and Research issued a warning letter to Mother Stem Institute, Corp. (Coral Gables, FL), founded by Dr. Alvaro Skupin, after reviewing the firm's website and records related to its stromal vascular fraction (SVF) product derived from enzymatic digestion of adipose tissue. The firm's website marketed the SVF product for treatment of Alzheimer's disease, Type I/II Diabetes, Lupus, Rheumatoid Arthritis, Parkinson's, and other conditions, establishing drug and biological product intended uses without an approved Biologics License Application or active IND. FDA found the SVF product constitutes more than minimal manipulation of a structural tissue, does not qualify for the same-surgical-procedure exception, and is both an unapproved biological drug and a misbranded drug, warning that failure to correct violations may result in seizure and/or injunction.
Flagged claims (5)
The best thing is this treatment is available to everyone in our facilities…
People who have common symptoms such as physical exhaustion, stress, insomnia, as well as people with chronic degenerative diseases such as type I and II diabetes, osteoarthritis, Parkinson's. It also favors people with autoimmune and inflammatory diseases such as Lupus, Rheumatoid Arthritis. An extensive list of diseases can be mentioned…
In July 2014, she underwent the stem cell procedure. At the end of the four months, the patient expresses feeling better, has more concentration to do household chores and feels more energy.
Stem cells have the ability to identify injured organs and tissues in the body, regenerating the damage found in their wake. The treatment consists of administering intravenously the patient's own stem cells (autologous).
Stem cells obtained from the patient's own fat (autologous) have opened a new door to conquer Alzheimer's disease because they manage to transform into the type of cells that the patient has lost. Not only does this suppress the death (apoptosis) of neurons in the brain, but it also has a preventative and therapeutic effect against Alzheimer's disease.
Required actions (3)
Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation.
We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations.
Failure to adequately address this matter may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
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