What it is
Stem cells are cells that can develop into other kinds of cells or help support tissues in the body. The term "stem cell therapy" is used for a very wide range of things, from established transplant medicine to newer clinic offerings, and those are not the same.
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. These are very different from most products advertised by walk-in clinics.
Most clinic treatments, including mesenchymal stem cell (MSC), adipose or SVF, umbilical cord, Wharton's jelly, perinatal and exosome products, are NOT FDA-approved. No exosome product is FDA-approved. The FDA has warned the public about unapproved stem cell and exosome products, and calling a practice "holistic" or "alternative" does not change that status.
How it’s traditionally been approached
Stem cell science has long been part of blood and immune medicine, where transplant specialists use carefully regulated cell products in hospital settings. This work is overseen closely and guided by licensed clinicians.
Regenerative medicine for areas such as joints and soft tissue is a newer and still-developing field. Researchers continue to study whether and how various cell-based approaches might help, and the evidence for many uses is limited or investigational.
Orthopedic practices, clinical research sites and integrative practices each approach this field differently. Some offer only conventional care, some run registered studies, and some offer unapproved products. Families often find it useful to understand which kind of setting they are dealing with.
How the right provider may help
The right licensed provider may help your family sort established options from investigational ones. A visit generally begins with a conversation about health history, current symptoms, past care and goals, and may include an exam or review of records. Only a licensed clinician can decide what is appropriate after an evaluation.
It can help to bring a trusted family member or caregiver to the appointment and write questions in advance. You might ask: Is this product FDA-approved? If not, why is it being offered? Is this part of a study registered on ClinicalTrials.gov with IRB oversight? What are the risks, and what are the alternatives, including doing nothing new?
Before agreeing to anything, verify the clinician's license with your state medical board and ask for written informed consent that covers risks and alternatives. A good provider should welcome these questions, and should be comfortable with you taking time or getting a second opinion.
The whole-person view
Body, mind and stress affect each other. Living with a painful or serious condition can be exhausting for the person and for the people around them, and the pressure to find an answer quickly can make big decisions feel urgent. Caring for your own wellbeing as a caregiver matters too.
Some families find support from body-based approaches such as those listed through Somatic Experiences, which focus on how stress is held in the body. Others find talk therapy through Therapists.plus helpful for coping with worry, grief or decision fatigue. These may be complementary supports and are not substitutes for medical care.
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 no website can replace an evaluation by a licensed clinician.
- Watch for red flags: claims that a treatment cures or "treats everything," being asked to pay to join a "clinical trial," testimonials offered in place of evidence, and pressure to travel abroad or across states for treatment.
- Never rely on promises about results, and be cautious about large upfront payments. Ask for everything in writing and take time to decide.
- For an emergency call 911. In a crisis call or text 988 (Suicide & Crisis Lifeline).
For your safety, sensitive situations are best guided by licensed professionals.
Providers who often help
Frequently asked questions
Is stem cell therapy FDA-approved?
Only a narrow set of stem-cell products is FDA-approved in the U.S.: cord-blood-derived hematopoietic progenitor cell (HPC) products for certain blood and immune disorders, used in specialist transplant settings. Most clinic stem cell therapy products, including MSC, adipose/SVF, umbilical cord, Wharton's jelly and perinatal products, are not FDA-approved. Ask any provider about the exact FDA status of what they are offering.
Are exosome treatments approved by the FDA?
No, no exosome product is FDA-approved. The FDA has warned the public about unapproved exosome products marketed by some clinics. Ask a licensed clinician about the regulatory status and any risks before considering one.
How can families check whether a stem cell clinic is trustworthy?
Start by confirming the clinician's license with your state medical board and asking whether the product is FDA-approved. If the clinic says it is a study, check that it is registered on ClinicalTrials.gov and has IRB oversight. Also ask for written informed consent that explains risks and alternatives.
What are the warning signs of a stem cell scam?
Common red flags include claims that a treatment cures or treats everything, being asked to pay to join a clinical trial, and testimonials used in place of evidence. Pressure to travel abroad or across states, or to decide quickly, is another warning sign. Calling a practice holistic or alternative does not change a product's FDA status.
What should we ask before a loved one agrees to stem cell therapy?
Ask what the product is, whether it is FDA-approved, what the evidence is and how limited it may be, and what the risks and alternatives are. Ask who will perform the procedure and whether they are licensed. It also helps to get a second opinion from another licensed clinician.
Can stem cell therapy replace surgery or other standard care?
No one can promise that it will, and families should be cautious about any claim that a treatment avoids surgery or regrows tissue. Evidence for many clinic uses is limited or investigational. A licensed clinician who has evaluated your loved one is the right person to discuss options and alternatives.
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.