SPECIALTY TOPICS · GUIDE
What Is Regenerative Medicine?
Regenerative medicine aims to repair or replace damaged cells, tissues or organs. This page separates the few approved products from the many unproven claims, with sources.
Content last updated . This page has not been medically reviewed.
Back to Emerging Wellness ScienceWhat the term means
One widely used definition describes regenerative medicine as replacing or "regenerating" human cells, tissues or organs to restore or establish normal function. [1] The same source says this can happen by replacing damaged tissue or by stimulating the body's own repair mechanisms. [1] It lists cell therapies, immunomodulation (using biologically active molecules or substances released by cells) and tissue engineering (laboratory-grown tissues) as examples of approaches. [1]In the European Union, regulators group related products as advanced therapy medicinal products, built on genes, tissues or cells. [2] Tissue-engineered medicines are the group that contain cells or tissues modified so they can repair, regenerate or replace human tissue. [2]
Field, technology and product are different things
"Regenerative medicine" is a field. Stem cells, scaffolds and cell-derived particles are technologies or materials. A specific licensed product with a defined indication is something else again. A result in one product does not carry over to others with similar names. See stem cells explained for the cell types and regulatory status of regenerative products for product-by-product detail.What natural repair can and cannot do
The National Institute of General Medical Sciences notes that in humans, regeneration is limited to processes like healing broken bones and skin cuts, while some animals can regrow whole body parts. [7] A claim that a product "regenerates" any tissue should be read against that limit. See differentiation, repair and replacement and claim check: "regenerates any tissue".How to read a regenerative claim
Ask which product it is, what condition it was tested for, whether the test was in cells, animals or people, and whether a regulator approved it. Our evidence labels use terms such as approved medicine, promising but limited, preclinical (cells or animals only) and marketing claim. A clinic offering a treatment does not mean it is approved. For plasma and exosome products see platelet-rich plasma and extracellular vesicles and exosomes.Frequently asked questions
Is regenerative medicine the same as stem cell therapy?
No. Stem cell therapy is one part of the field. The field also includes tissue engineering and approaches that stimulate the body's own repair. [1]
Are any stem cell products approved?
Yes, for specific uses. FDA lists licensed products such as cord-blood-derived blood-forming cell products and Ryoncil for a particular transplant complication. [3] [5] Approval for one use does not cover other uses.
Is a product safe if it comes from my own body?
Not necessarily. FDA's warning covers unapproved products whether recovered from your own body or another person's body. [6]
Where can I report a bad reaction?
FDA asks people who were hurt by a regenerative medicine product to report it to its MedWatch program. [8]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Examples that are approved medicines
- MACI is indicated in the United States for repair of symptomatic full-thickness cartilage defects of the knee, with or without bone involvement, in adults. [4]
- Ryoncil is indicated for steroid-refractory acute graft versus host disease in children 2 months of age and older. FDA calls it the first FDA-approved mesenchymal stromal cell therapy. [5]
Each approval is for one product and one condition. Neither means that "stem cells" in general are approved for other uses.
What is not approved
That FDA consumer page carries a 2024 "current as of" date, so check the live approved list for newer licensed products. [6]
References
- AABB. Regenerative Medicine. Read 2026-10-22.
- European Medicines Agency. Advanced therapy medicinal products: Overview. Read 2026-10-22.
- U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. Content current as of 09/17/2026. Read 2026-10-22.
- U.S. Food and Drug Administration. MACI (autologous cultured chondrocytes on porcine collagen membrane). Read 2026-10-22.
- U.S. Food and Drug Administration. FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients. Read 2026-10-22.
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. Content current as of 04/08/2024. Read 2026-10-22.
- National Institute of General Medical Sciences (NIH). What Are Stem Cells?. November 27, 2024. Read 2026-10-22.
- U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. July 22, 2020; content current as of 04/09/2024. Read 2026-10-22.