Stem cell therapies are often marketed to those with unresolved pain wanting a long-term solution without undergoing surgery. But Dr. Mark Hollmann warns, “there’s a lot of false and misleading information out there, including what some promoters are saying about stem cell therapy. The truth is, stem cell products have not been shown to be safe or effective for most orthopaedic ailments, and could actually be harmful.”

FDA Consumer Alert

Recently the FDA reemphasized it’s July 2020 Consumer Alert regarding the continued marketing of unapproved products considered regenerative medicine therapies.

In the advisory, “Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes, ” they wrote:

“Stem cell products are regulated by FDA, and, generally, all stem cell products require FDA approval. Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.”

Stem Cells are Not Approved for Orthopaedic Conditions

You may have been told that a specific stem cell procedure is FDA exempt because it uses the patient’s own cells as opposed to using somebody else’s tissue or cells. That is not true.

The FDA states, “Regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.”

Advice for People Considering Stem Cell Therapies

• Ask your provider if the FDA has reviewed their stem cell therapy treatment.
• Ask for the FDA-issued Investigational New Drug Application number and do your research before getting treatment.

If you are considering a regenerative medicine product and have questions about how it is regulated (including whether FDA approval is required), whether it is FDA-approved, or what to consider before participating in a clinical trial, we encourage you to contact the FDA at 800-835-4709 or email ocod@fda.hhs.gov for information.