What it is
Amniotic products are made from tissues associated with pregnancy. The amniotic membrane is the thin inner lining of the sac that surrounds a baby in the womb. Amniotic fluid is the liquid inside that sac. Some products also use related tissues, such as the placenta, umbilical cord or Wharton's jelly (the gel-like material inside the cord).
In the United States, the tissue is generally donated by a mother who has chosen to give it after a scheduled cesarean delivery. Donors are usually screened with health history questions and blood tests. The tissue would otherwise be discarded as medical waste.
After collection, a tissue bank or manufacturer cleans, tests and processes the tissue. It may be dried, frozen, sheeted or turned into a liquid or powder. Processing differs between companies. Many finished products contain no living cells, so they should not be called stem-cell treatments.
Source and processing are not the same as approval for a use. Amniotic membrane used as a wound covering and on the surface of the eye is the established use. Injectable amniotic, umbilical cord, Wharton's jelly and exosome products marketed for joints, pain, hair, skin or "regeneration" are generally not FDA-approved for those uses.
How it’s traditionally been approached
Amniotic membrane has been used in medicine for a long time, mainly as a biological covering for wounds and burns. Eye specialists also place it on the surface of the eye in certain situations. These are the best-established uses.
Over the years, companies began offering other forms, including injectable liquids and powders. These are often promoted for joint discomfort, skin, hair and general "healing." This area is newer, and the evidence and regulatory picture are different from the membrane's traditional uses.
The FDA has issued public warnings about unapproved regenerative products. Traditional care for the same concerns often includes things like rest, rehabilitation, medicines, procedures or surgery, depending on what a clinician finds. Each approach has its place.
How the right doctor may help
A licensed provider, such as a wound care clinician or a doctor at a regenerative medicine clinic, may help you sort out what a product is and whether it fits your situation. A visit generally starts with your history, your symptoms and an exam. Tests or imaging may be part of it, and that is up to the clinician.
A good provider can explain the choices in plain language. Those may include standard options as well as any amniotic product. They may be able to tell you if a product is cleared or approved for the use being discussed. No outcome can be promised.
Questions worth bringing: What is this product's FDA status for this use? What is its tissue source and how was it processed? What are the risks? What alternatives exist? What is the total cost, and will insurance cover it? Check with your insurer before treatment, and feel free to take time or get a second opinion.
The whole-person view
Body, mind and stress affect one another. Long-lasting pain, a slow-healing wound or worry about a health decision can all feel heavier when stress is high, and stress can in turn affect sleep, energy and comfort. Looking at the whole person is often a helpful frame.
Some people explore body-based support such as Somatic Experiences, while others find talk therapy through Therapists.plus useful when a health concern feels overwhelming. These can sit alongside medical care, and a licensed provider can help you decide what fits.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Amniotic membrane as a wound covering and on the eye surface is the established use; injectable amniotic, cord, Wharton's jelly and exosome products for joints, pain, hair, skin or regeneration are generally not FDA-approved for those uses.
- Most processed amniotic products contain no living stem cells, and no product should be expected to regrow cartilage or tissue or to guarantee results.
- Only a licensed clinician can decide what is appropriate for you after an evaluation, so ask about FDA status, risks, alternatives, total cost and insurance before treatment.
- Licensed professionals should guide care for serious conditions. For emergencies call 911, and in a crisis call or text the 988 Lifeline.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
Where do amniotic products come from?
Most amniotic products come from tissue donated by mothers after a healthy, scheduled cesarean birth. The tissue is screened, processed and distributed by a tissue bank or manufacturer. Ask your provider about the specific source of any product they suggest.
Are amniotic products made from embryos?
No. Amniotic products come from tissues around a baby, such as the membrane, fluid or placenta, after birth. They are not made from an embryo. Ask the provider where a specific product's tissue came from.
Does the donor or baby get harmed when tissue is donated?
Donation takes place after the baby is born, using tissue that would usually be discarded. The mother gives consent and is screened for health risks. Details vary by tissue bank, so a provider can explain what they know about their supplier.
Do amniotic products contain stem cells?
Most do not contain living stem cells after processing, even if marketing suggests otherwise. They should not be described as stem-cell treatments. Ask the provider what is actually in a product and how it was processed.
Are amniotic products FDA-approved?
It depends on the product and the use. Amniotic membrane as a wound covering and on the eye surface is the established use. Injectable products for joints, pain, hair, skin or regeneration are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved regenerative products.
What should I ask a provider about an amniotic product?
Ask about its FDA status for your use, tissue source, processing, risks, alternatives and total cost. Also check with your insurance before treatment. A licensed clinician can decide what is appropriate after evaluating you.
Educational resource. Amniotic Doctors shares general information and connects people with independent doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.