Stem cell clinic slapped with CBER warning – Regulatory Focus

Posted 12 October 2020 | By Kari Oakes 

Stem cell clinic slapped with CBER warning
A chiropractor who operates a stem cell clinic has received an untitled letter from the US Food and Drug Administration (FDA) for marketing intrathecal and intravenous injection of human stem cell and tissue-based products to treat such serious conditions as Parkinson’s disease and diabetes.
 
Michael Johnson runs Optimal Health Stem Cell and Wellness Institute, also doing business as OHSTEMCELL, in Appleton, WI. On 1 October, FDA’s Center for Biologics Evaluation and Research (CBER) sent Johnson, a chiropractic neurologist, a letter that referenced information on his firm’s website, Facebook page and YouTube channel.
 
Through his business, said the letter, Johnson markets umbilical cord-derived cellular products to treat a variety of serious or life-threatening conditions. Multiple sclerosis, autism, chronic obstructive pulmonary disease, Parkinson’s disease and traumatic brain injury are among the 21 conditions cited in the CBER letter.
 
The Facebook page for Johnson’s business also markets human adipose tissue- and amniotic membrane-derived products for conditions including such autoimmune disorders as systemic lupus erythematosus and Sjogren’s disease, as well as “adrenal fatigue” and other serious conditions.
 
To support the letter’s claim that Johnson intends his products to be administered intravenously or intrathecally, CBER pointed to a quote from one of OHSTEMCELL’s Facebook posts: “INTRATHECAL INJECTIONS! We use intrathecal
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