What it is
Umbilical cord stem cell therapy refers to treatments that use cells or tissue from the umbilical cord or cord blood. Cord blood contains hematopoietic (blood-forming) progenitor cells. Cord tissue, including a gel-like material called Wharton's jelly, contains other cell types, such as mesenchymal stromal cells (MSCs).
In the U.S., the only FDA-approved stem-cell products are cord-blood-derived hematopoietic progenitor cell (HPC) products. They are approved for certain blood and immune disorders and are used in specialist transplant settings, not as general-purpose treatments.
Most other products marketed as umbilical cord stem cell therapy are NOT FDA-approved. That includes many clinic offerings made from Wharton's jelly, cord tissue, perinatal tissue or exosomes. No exosome product is FDA-approved, and the FDA has warned the public about unapproved stem cell and exosome products. Calling a product holistic or alternative does not change its FDA status.
How it’s traditionally been approached
Cord blood has traditionally been collected at birth and stored, either in public banks or privately, for possible use in transplant medicine. Hematology and transplant centers use approved HPC products under the care of specialists for certain blood and immune conditions.
Researchers have also studied cord-derived and other perinatal cells for many other purposes. Much of this work is early-stage or investigational, and the evidence for most uses outside approved indications remains limited.
Some clinics offer cord-derived products for joint, skin, neurological or other concerns. These uses are generally not FDA-approved. Whether any product is appropriate is a decision for a licensed clinician after an evaluation, not for a marketing page.
How the right provider may help
The right provider may help you sort out which category a product falls into: an FDA-approved cord blood transplant product, an investigational study, or an unapproved clinic offering. A visit generally starts with a history, an exam and a review of your records and goals. A good clinician is comfortable discussing alternatives, including options that do not involve cells at all.
Questions worth asking: Is this product FDA-approved for my condition? If it is part of a study, is it registered on ClinicalTrials.gov and overseen by an institutional review board (IRB)? What are the known and unknown risks? What are the alternatives, including doing nothing or seeing a specialist?
Before moving forward, confirm the clinician's license with your state medical board and ask for written informed consent that covers risks and alternatives. Be cautious about 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.
The whole-person view
Body, mind and stress affect one another. Living with a health problem can be tiring and worrying, and stress can in turn change how we sleep, move and feel. Hope for a new treatment is natural, and it helps to pair that hope with careful, well-informed decisions.
Some people find that body-based support, such as the approaches offered through Somatic Experiences, helps them feel more settled while they work through health decisions. Others value talk therapy through Therapists.plus to process uncertainty or difficult choices. These are supportive options that complement, not replace, care from a licensed medical clinician.
Somatic Experiences: embodiment and movement →Somatic Experiences: nervous system regulation →Therapists.plus: mind body connection →
Keep in mind
- Only a licensed clinician can decide what is appropriate for you after an evaluation; this page is educational and not medical advice.
- Outside approved cord-blood HPC products, most umbilical cord stem cell treatments are not FDA-approved, and evidence for many uses is limited or investigational.
- Verify FDA status, study registration on ClinicalTrials.gov with IRB oversight, the clinician's state license, and written informed consent before any treatment.
- Serious conditions should be guided by licensed professionals. 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 umbilical cord stem cell therapy?
Umbilical cord stem cell therapy is a term for treatments that use cells from cord blood or cord tissue. The only FDA-approved versions in the U.S. are cord-blood-derived hematopoietic progenitor cell products for certain blood and immune disorders. Many other products sold under this name are not FDA-approved.
Is umbilical cord stem cell therapy FDA-approved?
Only cord-blood-derived HPC products are FDA-approved, and they are used in specialist transplant settings for certain blood and immune disorders. Most clinic products made from Wharton's jelly, cord tissue or other perinatal sources are not approved. Ask any provider directly about the FDA status of what they offer.
Are Wharton's jelly and cord tissue injections approved?
No, Wharton's jelly and similar cord tissue products offered at clinics are generally not FDA-approved. The FDA has warned the public about unapproved stem cell products. Evidence for their use is limited or investigational, so discuss risks and alternatives with a licensed clinician.
Are exosomes from umbilical cord approved by the FDA?
No, no exosome product is FDA-approved. The FDA has issued public warnings about unapproved exosome products. If a clinic offers them, ask what evidence exists and whether a registered, IRB-overseen study is involved.
How can I check whether a clinic or study is legitimate?
Confirm the clinician's license with your state medical board and ask about the product's FDA status. If a study is involved, look for it on ClinicalTrials.gov and ask about IRB oversight. Request written informed consent that explains risks and alternatives.
What are red flags with umbilical cord stem cell clinics?
Warning signs include claims to cure or treat everything, paying to join a 'clinical trial', testimonials used instead of evidence, and pressure to travel abroad or across states. Calling a treatment holistic or alternative does not change its FDA status. A licensed clinician can help you weigh any offer.
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.