What it is
A tissue bank is a facility that handles human tissue donated for medical use, such as bone, skin, corneas, tendons or amniotic membrane. Tissue banks may screen donors, recover tissue, process it, store it and send it to clinicians.
Accreditation is a review by an outside, professional body that checks whether a tissue bank meets published standards for things like donor screening, record keeping, cleanliness, labeling and tracking. Being accredited generally means a facility has been looked at against a standard. It is a quality signal, not a guarantee of any outcome.
Accreditation is not the same as FDA approval. In the United States, the FDA regulates human cells and tissue products and requires tissue establishments to register. Whether a specific product is FDA-approved, cleared or simply registered for a given use is a separate question, and it varies by product.
How it’s traditionally been approached
Tissue banking has long supported surgery and eye care. Donated tissue has been used for many years in settings such as bone grafting, wound care and procedures on the surface of the eye. Amniotic membrane as a wound covering and on the eye surface is the established use.
Over time, professional associations and regulators have set standards for how tissue is screened, processed and tracked. Facilities have traditionally relied on a mix of government oversight and voluntary accreditation to show they take safety seriously.
More recently, tissue-derived products have been marketed for joints, pain, hair, skin and so-called regeneration. Injectable amniotic, umbilical cord, Wharton's jelly and exosome products for these uses are generally not FDA-approved, and the FDA has warned the public about unapproved regenerative products. Many such products contain no living stem cells after processing, so they should not be described as stem-cell treatments.
How the right doctor may help
A licensed provider, such as a clinician at a regenerative medicine clinic or an orthopedics and sports medicine practice, may help you make sense of what a product is and what is known about it. A visit generally begins with a conversation about your history, your concerns and an evaluation. Only a licensed clinician can decide what is appropriate for you.
If a tissue-based product comes up, you can ask where it came from and which tissue bank supplied it. You can also ask whether that bank is accredited and registered with the FDA, and how you could confirm it yourself.
Other good questions: What is this product's FDA status for the use being discussed? What are the risks? What alternatives exist, including options that do not involve tissue products? What is the total cost, and does insurance cover it? Ask for answers in writing if you can, and feel free to get a second opinion.
The whole-person view
Health decisions involve the whole person. Body, mind and stress affect each other, and uncertainty about a procedure or a product can feel heavy. Taking time to learn the basics may help you feel steadier when you talk with a provider.
Some people find that body-based support, such as the practitioners listed through Somatic Experiences, helps them tune in to how stress shows up physically. Others like talking things through with a counselor, and Therapists.plus is one place to find talk therapy. These are complements to, not replacements for, care from a licensed clinician.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Accreditation of a tissue bank is not the same as FDA approval of a product, and it does not promise any result.
- Injectable amniotic, umbilical cord, Wharton's jelly and exosome products for joints, pain, hair, skin or regeneration are generally not FDA-approved for those uses, so ask a provider about the product's FDA status, tissue source, risks, alternatives and total cost, and check insurance before treatment.
- Licensed professionals should guide your care, and this page does not diagnose or recommend any treatment.
- For an emergency, call 911. If you are 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
What is tissue bank accreditation?
Tissue bank accreditation is a review by an outside professional body that checks whether a tissue bank follows published standards for donor screening, processing, storage, labeling and tracking. It is a quality signal about the facility. It does not guarantee that a product will work or that it is approved for a particular use.
Is an accredited tissue bank the same as FDA approved?
No. Accreditation is a voluntary review of a facility, while the FDA regulates human tissue products and the establishments that handle them. A product from an accredited bank may still not be FDA-approved for a given use, so ask your provider about that product's specific status.
Why does tissue bank accreditation matter for amniotic products?
It may offer some reassurance about how donor tissue was screened, handled and tracked. It does not make an unapproved use approved. Amniotic membrane as a wound covering and on the eye surface is the established use, while injectable products for joints, pain or hair are generally not FDA-approved.
How can I find out if a provider's tissue comes from an accredited bank?
Ask the provider directly for the name of the tissue bank and the product's source, and ask how you can verify its accreditation and FDA registration. A trustworthy provider should be willing to explain. You can also look up the accrediting body and FDA information on your own.
Are amniotic injections stem-cell treatments?
No, they should not be described that way. Most amniotic products contain no living stem cells after processing, and they are not shown to regrow cartilage or tissue. Ask your provider what the product actually contains and what its FDA status is.
What should I ask a doctor before any tissue-based treatment?
Ask about the product's FDA status, its tissue source and bank, the risks, the alternatives, and the total cost. Also check with your insurance before treatment. Only a licensed clinician can decide what is appropriate for you after an evaluation.
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.