What it is
Mesenchymal stem cells, often called MSCs, are cells that researchers have found in tissues such as bone marrow, fat (adipose) tissue and umbilical cord tissue. In laboratory settings they can develop into several cell types and release signaling molecules. Many scientists now call them mesenchymal stromal cells, because how they act in the body is still being studied.
Mesenchymal stem cell treatment generally means giving MSCs, or products made from them, to a person with the hope of supporting the body's own repair processes. Researchers are studying MSCs for many conditions. For most of those uses, the evidence is limited or still investigational.
Regulatory status matters here. In the U.S., the only FDA-approved stem-cell products are cord-blood-derived hematopoietic progenitor cell (HPC) products, used for certain blood and immune disorders in specialist transplant settings. Most clinic-offered MSC, adipose/SVF, umbilical cord, Wharton's jelly and perinatal products are NOT FDA-approved, and the FDA has warned the public about unapproved stem cell and exosome products. No exosome product is FDA-approved.
How it’s traditionally been approached
Traditionally, MSC work has taken place in research laboratories and in formal clinical studies. In these studies, investigators follow written protocols, have oversight from an institutional review board (IRB), and report what they find. This is different from a standard medical treatment with an established approval.
Outside of research, some clinics offer MSC-related products, often in orthopedic or wellness settings. Because most of these products are not FDA-approved, the FDA has raised public safety concerns. Calling a product 'holistic' or 'alternative' does not change its FDA status.
People exploring joint, tissue or other health concerns have usually started with conventional, evidence-based care. That care may include rest, physical therapy, medication, or surgery when a licensed clinician judges it appropriate. Anyone considering MSC options is encouraged to talk through these established paths first.
How the right provider may help
The right provider may help you sort out what is established, what is investigational, and what is simply marketing. A visit with a licensed clinician usually starts with a conversation about your history, your symptoms and your goals. It often includes an evaluation, and only the clinician decides what is appropriate for you. Nothing here promises any result.
Good questions to bring include: Is this product FDA-approved for my condition? If not, is it offered inside a study registered on ClinicalTrials.gov with IRB oversight? What are the risks, and what are the alternatives, including doing nothing? Who will manage problems if they come up afterward?
You can also check that the clinician's license is active with your state medical board. Ask for written informed consent that covers risks and alternatives, and take time to decide. A trustworthy provider welcomes questions and a second opinion. Directories such as Providers.plus list licensed providers, and MSC clinical research sites and orthopedic regenerative medicine practices are two types you may come across.
The whole-person view
Body, mind and stress affect one another. Ongoing pain, a health scare or a long recovery can raise stress, and stress can change sleep, energy and how the body feels. Looking at the whole person, including movement, rest, nutrition and emotional well-being, is a sensible part of any health decision.
Some people find body-based support helpful, such as the approaches listed through Somatic Experiences. Others value talking things through with a licensed professional, which you can explore through Therapists.plus. These are supportive options, not substitutes for medical care, and no approach is better or worse than another for everyone.
Somatic Experiences: embodiment and movement →Somatic Experiences: nervous system regulation →Therapists.plus: mind body connection →
Keep in mind
- Most mesenchymal stem cell treatment offered by clinics is not FDA-approved, and the FDA has warned the public about unapproved stem cell and exosome products. Always verify a product's FDA status.
- Red flags include cure-all or 'treats everything' claims, paying to join a 'clinical trial', testimonials used in place of evidence, and pressure to travel abroad or across states for treatment.
- Licensed professionals should guide care for any serious condition. This page is educational only and is not medical advice.
- For an emergency, call 911. In a crisis, call or text 988.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
What is mesenchymal stem cell treatment?
Mesenchymal stem cell treatment is the use of MSCs, or products made from them, with the aim of supporting the body's repair processes. Most uses are still being studied, and the evidence is limited or investigational. A licensed clinician decides what is appropriate after an evaluation.
Is mesenchymal stem cell treatment FDA-approved?
No, not for most uses. In the U.S., the only FDA-approved stem-cell products are cord-blood-derived hematopoietic progenitor cell (HPC) products for certain blood and immune disorders. Most clinic MSC products are not FDA-approved, so ask your provider about the status of any product.
Where do mesenchymal stem cells come from?
MSCs are described as coming from tissues such as bone marrow, fat tissue and umbilical cord tissue. The source and how the cells are processed can differ a lot between products. Ask a provider exactly what is used and what its regulatory status is.
Is mesenchymal stem cell treatment safe?
Safety depends on the product, how it is made and who gives it, and unapproved products carry unknowns. The FDA has warned the public about unapproved stem cell products. Ask a licensed clinician about risks and alternatives, and get written informed consent.
How can I tell if an MSC clinic or study is legitimate?
Check that any study is registered on ClinicalTrials.gov and has IRB oversight, and confirm the clinician's license with your state medical board. Be cautious of cure-all claims, fees to join a 'trial', testimonials in place of evidence, and pressure to travel. Get the risks and alternatives in writing.
Are exosomes the same as mesenchymal stem cell treatment?
No. Exosomes are tiny particles released by cells, and they are not the same as the cells themselves. No exosome product is FDA-approved, and the FDA has warned the public about unapproved exosome products.
Educational resource. StemCell.biz shares general information and connects people with independent providers. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.