What it is
Regenerative medicine is a broad term. It covers laboratory research, established medical procedures, and a wide range of clinic services that use the body's own tissues or donated biological materials. Because the term is used so widely, two clinics that both say "regenerative" can offer very different things.
Stem cell therapy is one part of this field. In the U.S., the only FDA-approved stem-cell products are cord-blood-derived hematopoietic progenitor cell (HPC) products. They are used for certain blood and immune disorders in specialist transplant settings.
Most other clinic offerings are not FDA-approved. That includes MSC, adipose or SVF, umbilical cord, Wharton's jelly and other perinatal products, and exosome products. No exosome product is FDA-approved, and the FDA has warned the public about unapproved stem cell and exosome products. Calling a service "holistic" or "alternative" does not change its FDA status.
How it’s traditionally been approached
Traditionally, people with joint, muscle, nerve or other health concerns have started with a primary care or specialist visit. That visit usually includes a history, an exam, and sometimes imaging or lab work. Conservative options and established procedures are typically discussed first.
Regenerative approaches have often been explored later, or alongside other care, when a person is looking for more options. Some are offered inside formal clinical research. Others are offered in private clinics outside of research, and that is where regulatory status matters most.
Careful patients have long used a simple habit: ask questions, get the answers in writing, and consider a second opinion. The same habit applies here, and a good clinician will usually welcome it.
How the right provider may help
The right provider may help you sort through the options clearly. A first visit often includes a review of your health history, an exam, and a conversation about your goals. A thoughtful clinician explains what is established, what is investigational, and what is unknown. This is a possibility, not a promise of any result.
Good questions to bring: Is this product FDA-approved for my condition? If not, what is its regulatory status? Is this part of a study registered on ClinicalTrials.gov with IRB oversight? What is your license, and what is your training? What are the risks, the alternatives, and the option of doing nothing? What happens if something goes wrong, and who handles follow-up care?
Also ask for written informed consent that covers risks and alternatives, and take time to read it. Confirm the clinician's license with your state medical board. You can ask about the evidence for your specific situation, and a trustworthy provider will describe it as limited or investigational where that is true. Only a licensed clinician can decide what is appropriate for you after an evaluation.
The whole-person view
Body, mind and stress affect each other. Long-lasting pain or health uncertainty can bring worry, poor sleep and tension, and those can in turn make the body feel worse. Looking at the whole person can be a helpful part of any decision. It also makes it easier to ask questions without feeling rushed.
Some people find body-based support, such as the approaches listed through Somatic Experiences, useful for working with stress held in the body. Others value talk therapy through Therapists.plus to sort through big decisions and the emotions around them. Neither replaces medical care, and both are simply ways of supporting yourself while you gather information.
Somatic Experiences: embodiment and movement →Somatic Experiences: nervous system regulation →Therapists.plus: mind body connection →
Keep in mind
- Educational only: this page is not medical advice, and only a licensed clinician can decide what is appropriate for you after an evaluation.
- Verify the product's FDA status, and check that any study is registered on ClinicalTrials.gov with IRB oversight. Also confirm the clinician's license with the state medical board.
- Red flags include cure-all or "treats everything" claims, paying to join a "clinical trial", testimonials offered in place of evidence, and pressure to travel abroad or across states for treatment.
- For serious conditions, licensed professionals should guide your care. For emergencies call 911, and 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 are the most important questions to ask a regenerative medicine doctor?
Start by asking whether the product is FDA-approved for your condition, and what its regulatory status is if it is not. Then ask about the doctor's license and training, the risks, the alternatives, and what follow-up care looks like. Ask for everything in writing, including the consent form.
Is stem cell therapy FDA-approved?
Only in limited cases. 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, used in specialist transplant settings. Most clinic stem cell, MSC, adipose/SVF, umbilical cord, Wharton's jelly and exosome products are not FDA-approved, and the FDA has warned the public about them.
How do I check whether a regenerative medicine doctor is licensed?
Look up the clinician on your state medical board's website to confirm that the license is active and to see any public actions. You can also ask about board certification and training. A reputable provider will be glad to share this information.
How can I tell if a stem cell clinical trial is legitimate?
Check that the study is registered on ClinicalTrials.gov and that it has IRB (institutional review board) oversight. Be cautious if you are asked to pay to join a "clinical trial", since that can be a red flag. Ask the study team to explain the risks, the purpose, and your right to leave.
What red flags should I watch for at a regenerative medicine clinic?
Watch for cure-all or "treats everything" claims, testimonials used in place of evidence, and pressure to decide quickly. Pressure to travel abroad or across states for treatment is another warning sign. Also be wary of any promise of results, since no honest provider can guarantee them.
Should I get a second opinion before stem cell therapy?
Yes, a second opinion is a sensible step for any significant health decision. A different licensed clinician can review your records, explain established options, and help you weigh the risks and alternatives. A trustworthy provider will support this.
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.