FDA Warns Consumers About Potential False Advertising Of Regenerative Products Using Stem Cells and Exosomes

A new warning issued by federal regulators indicates that some manufacturers are overselling the benefits of regenerative treatments that involves stem cells and exosomes; and in some cases, are outright lying, which may place patients’ health at risk.

On July 22, the FDA issued a consumer alert on regenerative medicine products, expressing concern that patients with serious conditions, desperate for a cure, are being deceived by unscrupulous companies illegally marketing stem cell or exosome treatments that have not been shown to be safe or effective.

The agency has made similar warnings in the past, when falsely advertised treatments popped up that claimed to treat neurologic disorders, like dementia. Now, the FDA is again warning consumers to take a closer look at such claims, which are cropping up again claiming these treatments can be used on COVID-19 patients.

“Using these products may lead to delays in getting a proper diagnosis and could also discourage patients suffering from serious illnesses from receiving safe and effective treatments that may be available,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA Voices blog post. “What’s also concerning is that we know that because these products are not FDA-approved, it’s very likely that adverse events are underreported by health care providers who treat patients with these products, and by patients who may have been harmed.”

Stem cells are the basis for all other cells in the human body. They are the root source of all other specialized cells, and thus it is believed they can be manipulated to become almost any type of specialized cell the body needs, which is extremely useful in replacing diseased or damaged cells that perform important functions. This means they could, for example, be programmed to replace specific types of brain cells, or potentially fix damaged nerves.

However, many of those uses have not yet been achieved.

Exosomes are structures secreted from cells and are believed to be how cells communicate and transmit vital proteins and DNA. However, despite the obvious potential benefits, there is still a lot about exosomes which is unknown.

The FDA warns that no exosome or stem cell therapies have been approved to treat or prevent COVID-19 or any complication related to the infection. The agency also notes it has never approved either technique to treat any orthopedic condition, neurological disorder or cardiovascular or pulmonary disease.

This means there are no approved, safe stem cell treatments for acute respiratory distress syndrome (ARDS), osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, shoulder pain, multiple sclerosis, Lou Gehrig’s disease, Alzheimer’s disease, Parkinson’s disease, epilepsy, stroke, heart disease, emphysema, chronic obstructive pulmonary disease (COPD), autism, macular degeneration, blindness or fatigue.

There has never been any approved exosome treatment at all.

The FDA warns consumers to be cautious of any clinic claiming to offer stem cell or exosome treatments for any of the above ailments.

Attempting these treatments could result in patients receiving proper diagnosis and treatment for serious illnesses and could lead to serious harm if used.

The FDA made a similar warning late last year after the agency and the Nebraska Department of Health and Human Services received several reports of patients becoming ill after receiving  stem cell products marketed as containing exosomes. Several required hospitalization.

In December 2018, the FDA issued another such warning, indicating some patients receiving stem cell treatments developed serious infections. The agency indicated that the treatments were not prepared according to proper guidelines, causing the stem cells to become contaminated.

The FDA is encouraging any patient or health care professional who has experienced adverse events linked to the use of these types of treatments to submit a report to the FDA MedWatch Adverse Event Reporting program.