Regenerative Medicine: What It Is and What the Evidence Shows
Medically reviewed by Harsha Moole, MD, Internal Medicine. Last reviewed: October 23, 2026.
What kind of doctor provides Regenerative Medicine?
The right doctor depends on the condition and the treatment. An orthopedic surgeon, a doctor who treats bones and joints, may use platelet-rich plasma for injuries. A direct primary care or concierge doctor can be a first stop for an evaluation and can refer you to a specialist when needed.
What it is
Regenerative medicine is a field that develops ways to regrow, repair, or replace damaged or diseased cells, organs, or tissues. It often includes the use of therapeutic stem cells. Stem cells are immature cells that can turn into other cell types. The FDA regulates regenerative medicine products. The unapproved products FDA lists include stem cells, fat-derived cells, and umbilical cord blood. Some of these products come from your own body, and others come from another person's body.
What people use it for
Many unapproved products are sold for a wide range of health problems. Transplants of blood and bone marrow stem cells have been used for more than 40 years to treat blood disorders. AAOS describes platelet-rich plasma, called PRP, a treatment made from a person's own blood. Some athletes have received it for problems such as sprained knees and chronic tendon injuries.
How to prepare
FDA says these products need FDA approval to be sold to consumers. FDA warns that you are likely being deceived if you are charged for these products or offered them outside of a clinical trial. A company being registered with FDA does not mean its product is legally sold. AAOS says to check with your health insurance carrier before PRP, since few plans pay any part of the cost.
What happens during it
For PRP, blood is first drawn from you. Spinning the blood separates the platelets from other blood cells. This is called centrifugation. The platelets are then injected into the injured site.
Recovery
AAOS gives one example for PRP. After an injection for Achilles tendinitis, pain at the injection site may increase for the first week or two. It may be several weeks before the patient feels a benefit.
Call 911 or go to the emergency room if you have trouble breathing, chest pain or discomfort lasting two minutes or more, fainting, coughing up or vomiting blood, or bleeding that will not stop.
What the research shows and safety concerns
AAOS says it is not exactly clear how PRP works. AAOS says PRP does appear to be effective for certain chronic tendon injuries. For broken bones, PRP has shown no significant benefit so far. AAOS says more scientific evidence is needed to know whether PRP truly works for other conditions. AAOS says the risks of PRP are minimal, with possible increased pain at the injection site.
FDA says the products it warns about are not approved for any condition of the bones, joints, or tendons, such as osteoarthritis, tendonitis, or tennis elbow. FDA has received reports of blindness, tumor formation, and infections from the use of these unapproved products. FDA lists these safety concerns.
- Bacterial infections, including life-threatening blood infections.
- Reactions at the site of collection and administration.
- Failure of the therapy to work as anticipated when approved treatments are available.
Who performs it
An orthopedic surgeon may use PRP for injuries to bones, joints, and tendons.
Common questions
Is stem cell therapy approved by the FDA?
Only blood-forming stem cell products made from umbilical cord blood are FDA approved. They are approved for disorders that affect the production of blood, but not for other uses.
Is regenerative medicine the same as stem cell therapy?
No. Stem cells are often part of regenerative medicine, along with tissue engineering and artificial organs.
What is PRP?
PRP stands for platelet-rich plasma. PRP is plasma with many more platelets than what is typically found in blood.
What should I do if a clinic offers me a stem cell product?
Contact FDA at [email protected] if you are offered these products outside of a clinical trial for which FDA has oversight. FDA also encourages you to report a bad side effect to its MedWatch program.
How does a direct primary care or concierge doctor fit in?
A direct primary care doctor charges a flat monthly fee instead of billing insurance, while a concierge doctor usually charges more and often works alongside insurance.
Sources
- U.S. Food and Drug Administration - Important Patient and Consumer Information About Regenerative Medicine Therapies
- National Eye Institute - Regenerative Medicine Patient and Public Resources
- American Academy of Orthopaedic Surgeons - OrthoInfo - Platelet-Rich Plasma (PRP)
Medical Disclaimer
This content is for general educational and informational purposes only and is not medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment, and reading it does not create a doctor-patient relationship. Always seek the advice of your physician or another qualified health provider with any questions about a medical condition, and never disregard or delay seeking professional advice because of something you read here. If you think you may have a medical emergency, call 911 (or your local emergency number) immediately.
