A Wisconsin stem cell clinic has been cautioned by the FDA for marketing intrathecal and intravenous injections of human stem cell and tissue-based products for a variety of neurologic conditions, according to the Regulatory Affairs Professionals Society.
The FDA's Center for Biologics Evaluation and Research on Oct. 1 sent a warning letter to Michael Johnson, DC, a neurologic chiropractor who runs Optimal Health Stem Cell and Wellness Institute in Appleton, Wis.
The letter cited claims on the practice's website, Facebook and YouTube channel, which marketed stem cell-based products derived from human adipose tissue, amniotic membrane and the umbilical cord.
According to the practice's website, conditions treated range from Parkinson's disease to multiple sclerosis and traumatic brain injuries. The FDA has not approved any stem cell products for orthopedic, neurological or cardiovascular conditions yet.
One recent Facebook post said, "we use intrathecal injections into the spine with chronic neurological patients," and claimed that having "stem cells cross the blood-brain barrier helps the neurological patient to heal faster," according to RAPS.
The lawful marketing of these products requires a biologics license, which the FDA said the practice does not have.
The letter added that "such unapproved uses raise potential significant safety concerns," with the methods used by the practice to administer the products another safety issue due to the "range of adverse events" that can arise from contaminated products injected intrathecally or intravenously.
While there is a lot of hype about the impact of stem cell-based products in neurology and orthopedics, there remains a significant lack of evidence, with many physicians calling for increased regulation and guidance in how these products are marketed.