What it is
Informed consent is more than a signature on a form. It is an ongoing conversation in which a licensed clinician explains the proposed procedure, its purpose, its possible risks and benefits, reasonable alternatives (including doing nothing), and what is uncertain. You then decide, without pressure, whether to proceed.
In regenerative medicine, consent matters especially because many offerings are new, investigational, or unapproved. 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-based stem cell therapy, including MSC, adipose/SVF, umbilical cord, Wharton's jelly, and perinatal products, is not FDA-approved.
No exosome product is FDA-approved either, and the FDA has warned the public about unapproved stem cell and exosome products. A sound consent discussion should say plainly whether a product is approved, being studied under an appropriate oversight process, or neither. Calling an approach "holistic" or "alternative" does not change its FDA status.
How it’s traditionally been approached
Informed consent grew out of medical ethics and patient-rights principles, and it is a standard expectation across healthcare, from surgery to medications. The idea is that people have the right to understand and choose what happens to their bodies.
Traditionally, consent is documented in writing for procedures with meaningful risk, and clinicians are expected to answer questions in plain language. For research, consent is overseen by an Institutional Review Board (IRB), an independent group that reviews studies to help protect participants.
Regenerative procedures have been approached in several settings: transplant centers using FDA-approved HPC products, registered clinical studies, and private clinics offering unapproved products. Each setting carries different oversight, and the consent conversation should reflect which one you are in.
How the right provider may help
The right provider may help by slowing the process down and making sure you understand your options. A visit often begins with a medical history and evaluation, followed by a discussion of what is and is not known about a proposed procedure. Only a licensed clinician can decide what is appropriate for you after an evaluation, and no outcome can be promised.
Good questions to ask include: Is this product FDA-approved for my condition? If not, why is it being offered, and is it part of a study registered on ClinicalTrials.gov with IRB oversight? What are the risks, the unknowns, and the alternatives, including conventional care? Who will perform the procedure, and what happens if something goes wrong?
Before agreeing, you can verify the clinician's license with your state medical board, ask for the consent document in writing, and take it home to review. Many people find it helpful to get a second opinion from an independent licensed clinician who has no financial stake in the decision.
The whole-person view
Health decisions involve the whole person. Worry about a painful or limiting condition, hope for relief, and pressure from a sales-style conversation can all shape how we weigh information. Stress can also affect how the body feels and how clearly we process choices, so giving yourself time and support is reasonable.
Some people find body-based support, such as the approaches listed through Somatic Experiences, helpful for noticing tension and stress while they weigh a decision. Others value talking through fears and expectations with a counselor, such as those found through Therapists.plus. These are complementary options and do not replace guidance from a licensed medical clinician.
Somatic Experiences: embodiment and movement →Somatic Experiences: nervous system regulation →Therapists.plus: mind body connection →
Keep in mind
- Licensed professionals should guide care for any serious condition, and nothing here replaces an evaluation by a licensed clinician.
- 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.
- Verify a product's FDA status, confirm that any study is registered on ClinicalTrials.gov with IRB oversight, check the clinician's license with your state medical board, and get written consent covering risks and alternatives.
- For emergencies 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 informed consent for regenerative procedures?
Informed consent for regenerative procedures is the process of a licensed clinician explaining a proposed treatment, its risks, unknowns, benefits, and alternatives so you can make a voluntary decision. It should include the product's regulatory status and be documented in writing. You should be free to ask questions and decline.
Is stem cell therapy FDA-approved?
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 therapy, including MSC, adipose/SVF, umbilical cord, Wharton's jelly, and perinatal products, is not FDA-approved. The FDA has warned the public about unapproved products.
What should an informed consent form include?
It should describe the procedure, its purpose, possible risks, uncertainties, and reasonable alternatives, including not treating. It should also state whether the product is FDA-approved or investigational and who is responsible if complications occur. Ask for a copy to review before you sign.
How do I know if a regenerative treatment is part of a real clinical trial?
Check whether the study is registered on ClinicalTrials.gov and whether it has IRB oversight. Be cautious if you are asked to pay to join a "clinical trial." A provider should be able to share the registration details and the consent document for the study.
Are exosome treatments FDA-approved?
No, no exosome product is FDA-approved. The FDA has warned the public about unapproved exosome products. Ask any provider offering them to explain their regulatory status and the risks in writing.
How can I check a clinician's credentials before consenting?
Confirm the clinician's license with your state medical board, which typically lists license status and any public disciplinary actions. You can also ask about their training and experience with the specific procedure. A second opinion from an independent licensed clinician may also help.
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.