The FDA recently released a consumer warning about regenerative medicine therapies in an effort to educate consumers about the marketing of unapproved products that claim to treat or cure medical conditions.
We asked board certified orthopedic surgeon and sports medicine specialist Dr. John McDonald to further explain what the FDA warning means for consumers and how you can differentiate between approved and unapproved emerging therapies in orthopedics.
What is regenerative medicine therapy?
Regenerative medicine therapy is the process of replacing or “regenerating” damaged or diseased cells, tissues or organs using cells recovered from your own body or another person’s body. This can include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells, amniotic fluid, Wharton’s jelly, orthobiologics, and exosomes.
Regenerative medicine is an advancing area of medical treatment, and its use is rapidly evolving.
Have any regenerative medicine therapies been approved by the FDA to treat orthopedic conditions?
Regenerative medicine therapies have not been FDA approved for the treatment of any orthopedic condition including osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.
Currently, stem cells are only approved by the FDA as treatments for certain blood and immune disorders. There are no other approved uses for these stem cells outside of investigational clinical studies.
Are there any reported side effects of using regenerative therapies?
The FDA has reported that some patients have have suffered significant bacterial infections, paraplegia and loss of vision from the use of unapproved products.
Why is there a demand for regenerative medicine?
The demand for less invasive treatments and faster recovery from injury is creating a market for regenerative medicine products. Consumer demand and willingness to pay for new treatments despite not being covered by insurance is also driving false claims and advertising.
Clinics often overemphasize the potential benefits without stating the risk, claiming patients can ‘grow new cartilage’ or other tissue. To date, there is very little evidence that available cell-based treatments for musculoskeletal conditions result in the increased formation of new tissue.
According to the American Academy of Orthopaedic Surgeons it is the clinician’s responsibility to inform patients of the risks, benefits and regulatory status of products offered so patients can make an informed decision about their treatment plan.
Is platelet-rich plasma considered regenerative medicine?
Platelet-rich plasma (PRP) is a type of orthobiologic therapy in which a patient’s own platelets are separated from other blood cells in a centrifuge and then injected into the injured area to help quicken the healing process or improve pain.
PRP is not FDA-approved but it can be legally offered ‘off-label’ for musculoskeletal conditions including muscle strains and soft tissue injuries.
Texas Orthopedics physicians may recommend PRP injections for certain injuries, arthritis, or after surgery to aid in your recovery.
Talk to your doctor.
Dr. McDonald encourages patients with bone and joint problems to speak with a physician who commonly treats musculoskeletal conditions to discuss both traditional and regenerative options so that the full picture of available scientific evidence and treatments are understood.