Stem cell clinic slapped with CBER warning

Regulatory NewsRegulatory News | 12 October 2020 |  By 

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 injections into the spine with chronic neurological patients like MS, Parkinson’s and stroke rehab patients. An intrathecal injection allows the stem cells to cross the blood-brain barrier. Having the stem cells cross the blood-brain barrier helps the neurological patient to heal faster!”
CBER’s letter clarifies that lawful marketing of OHSTEMCELL’s products would require that they have biologics licenses, which they do not. “Such unapproved uses raise potential significant safety concerns,” said CBER, adding that the risky routes of administration heighten the agency’s concern, since contaminated products injected intrathecally or intravenously “could cause a range of adverse events.”
The letter is part of CBER’s ongoing work to regulate the broader field of regenerative medicine. In a consumer-facing page on its website, FDA notes that “There is a lot of misleading information on the internet about these products, including statements about the conditions they can be used to treat.” The agency encourages reporting through its MedWatch adverse event reporting system.
In its warning letter, as in previous letters to stem cell clinics, CBER refers Johnson to its policy framework for human cells, tissues, or cellular or tissue-based products (HCT/Ps) as delineated in a series of four guidance documents. No stem cell products have, to date, been approved to treat any orthopedic, neurologic, cardiovascular, or pulmonary disease, or to treat many of the other conditions referred to in the CBER letter.
The OHSTEMCELL website calls stem cell therapy “one of the most cutting-edge and revolutionary natural therapies available,” but also asserts that “Stem cell therapy DOES NOT cure or treat any disease!” (emphasis original). The website asserts that “Stem Cells will repair and regenerate tissue and patients will show improvements for a period of up to 12-months…. Once healed, it is a permanent correction!”
The website also asserts that “the FDA has specific guidelines for cellular therapy and we follow these guidelines to the letter!” A typical testing and treatment course, according to the website, will cost patients between $21,000 and $30,000.
“Manufacturers and health care professionals who have any uncertainty regarding the regulatory status of their products are encouraged to contact FDA to obtain a recommendation or decision regarding the classification of an HCT/P,” said CBER in its letter, which requests a written response within 30 days of the letter’s receipt.


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Tags: biologics, FDA, US

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