Hot off the press of the FDA!!!

For some time, I have been cautioning patients about seeking care in practices using allogeneic(sources not from your own body) commercial umbilical cord products and advertising them as stem cells. Numerous laboratory studies prove that they contain NO stem cells. Some practices even go so far as to claim there are no side effects with these products. Now, the FDA is cracking down and produced a formal statement, based on multiple reports of serious adverse events.

Per the FDA statement printed yesterday, 12/6/19 “…multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes….

There are currently no FDA-approved exosome products. Certain clinics across the country, including some that manufacture or market violative “stem cell” products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products – that is simply untrue.”

Visit www.fda.gov to read more.