What it is
The umbilical cord and the tissues around birth (placenta, amniotic membrane and fluid) contain a mix of cells, proteins and structural material. Cord blood is the blood left in the cord and placenta after a baby is born. Wharton's jelly is the gel-like connective tissue inside the cord that surrounds its blood vessels.
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. That is a specific, narrow use and is different from what most clinics advertise as umbilical cord stem cell therapy.
Most clinic offerings, including Wharton's jelly, mesenchymal stem cell (MSC), umbilical cord, perinatal tissue 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 something holistic or alternative does not change its FDA status.
How it’s traditionally been approached
Cord blood has traditionally been collected at birth, with parental consent, and stored in public or private banks. When used in approved settings, it has been part of transplant medicine for certain blood and immune conditions, guided by transplant specialists.
Amniotic, placental and cord tissue products have been used in various forms, such as tissue grafts in some surgical and wound-care settings. Whether a given product is regulated as a tissue, a drug or a biologic depends on how it is processed and how it is intended to be used.
Beyond those settings, researchers have studied perinatal cells and tissues in clinical trials for many questions. The evidence for most uses outside approved indications is limited or investigational, and results from early research should not be read as proof that a clinic treatment works.
How the right provider may help
A thoughtful provider may help you sort marketing language from regulatory reality. A first visit generally involves reviewing your history, current care and goals, and discussing whether any evaluation or referral makes sense. A licensed clinician alone decides what is appropriate for you after an evaluation.
Good questions to ask include: Is this specific product FDA-approved for my condition? If not, is it offered within a study registered on ClinicalTrials.gov with IRB oversight? Where does the product come from, and how is it processed? What are the risks, and what are the alternatives, including doing nothing?
Also confirm the clinician's license with your state medical board and ask for written informed consent that covers risks and alternatives. Understanding the difference between donor stem cells and your own cells, and why that matters for safety and regulation, is another useful topic to raise with a provider.
The whole-person view
Body, mind and stress affect each other. Living with a health concern, or hoping for a breakthrough, can bring worry, hope and pressure to decide quickly. Sleep, movement, nutrition, relationships and stress levels all play a part in how people feel day to day.
Body-based approaches such as those from Somatic Experiences may help some people build awareness of how stress shows up physically, and talk therapy through Therapists.plus may offer support for the emotions around health decisions. These are supportive options that can sit alongside, not replace, care from a licensed 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.
- 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.
- Never quote or rely on promised results: evidence for most non-approved cord and perinatal uses is limited or investigational, and no treatment should be presented as avoiding surgery or regrowing tissue.
- For emergencies call 911; in a crisis call or text the 988 Lifeline. Serious conditions should be guided by licensed professionals.
Guides in this topic
Provider types
Frequently asked questions
Is umbilical cord stem cell therapy FDA-approved?
Only cord-blood-derived hematopoietic progenitor cell (HPC) products are FDA-approved, and they are used for certain blood and immune disorders in specialist transplant settings. Most other umbilical cord stem cell therapy offered by clinics is not FDA-approved. The FDA has warned the public about unapproved stem cell products, so ask a provider to explain the status of any product.
What are Wharton's jelly stem cells?
Wharton's jelly stem cells are cells derived from the gel-like tissue inside the umbilical cord. Wharton's jelly products marketed by clinics are generally not FDA-approved, and evidence for their use is limited or investigational. Ask a licensed clinician and verify any claims before considering one.
What are cord blood stem cell uses?
Approved cord blood stem cell uses are limited to HPC products for certain blood and immune disorders, given in specialist transplant settings. Other uses are being studied in research, but evidence is limited. A transplant specialist can explain whether this applies to a specific situation.
What is a perinatal tissue allograft?
A perinatal tissue allograft is tissue from a donor's birth-related sources, such as amniotic membrane or placenta, used in another person. How it is regulated depends on how it is processed and intended to be used. Ask a provider whether a specific product is FDA-approved or offered under a registered study.
What is the difference between donor stem cells and your own?
Donor (allogeneic) stem cells come from another person, while your own (autologous) cells come from your body. They differ in sourcing, processing, safety considerations and regulation. Neither label makes a product FDA-approved, so ask a licensed clinician about the specific product and its risks.
How can I check a clinic offering cord stem cell treatments?
Verify the product's FDA status, confirm the clinician's license with your state medical board, and check that any study is registered on ClinicalTrials.gov with IRB oversight. Ask for written informed consent covering risks and alternatives. Be cautious of cure-all claims, fees to join a trial, testimonials instead of evidence, and pressure to travel.
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.