FDA‘s CBER warns clinic in Wisconsin
The FDA sent an untitled letter to Michael Johnson, a chiropractor who runs a clinic called Optimal Health Stem Cell and Wellness Institute, located in Appleton, Wisconsin. The FDA’s Center for Biologics Evaluation and Research (CBER) wrote the letter. It cites 21 conditions that are mentioned by the clinic that do not have regulatory approval.
The CBER letter specifies an issue with the administration of the treatment proposed:
“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 states that lawful promotion of OHSTEMCELL’s products would require biologics licenses, which they do not have.
“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.”
CBER’s ongoing oversight includes such vigilance to monitor the field of regenerative medicine. FDA highlights on their website 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 suggests reporting via its MedWatch adverse event reporting system.
In its warning letter, as in previous letters to stem cell clinics, CBER refers Johnson to its policy guidelines for human cells, tissues, or cellular or tissue-based products (HCT/Ps) as described in 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 mentioned to in the CBER letter.
“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,” expressed CBER in its letter. They expect a written response from Michael Johnson within 30 days of the letter’s receipt.