Live stem cells are allowed by the FDA under 2 sections of the Public Health Service Act (Section 351 and 361) which provides the authority for FDA to establish regulatory requirements for marketing traditional biologics and human cells, tissues, and cellular and tissue-based products.
These two pathways differ markedly in terms of the time, effort and expense required to bring these products to market in the U.S.
One is the simple 361 registration, and the other is the complex 351 cell-drug approval. We only use your own stem cells (Autologous Stem Cells), which we use carefully so that we are compliant under Section 361 of the Public Health Service Act and the same day surgical exception.
351 : cell-drug approval:
complex and expensive registration
All of the orthopedic amniotic and cord products on the market today have the simple 361 registration, which, unlike a drug approval, requires no clinical trials or data.
If they are live umbilical cord stem cells or live amniotic stem cells, then they do not meet Section 361 criteria and are not allowed.
Currently, there are no live FDA approved or allowed umbilical cord, amniotic, placental or exosome products. If any provider or company that claims to use “FDA approved” live cord or live amniotic cells or any exosomes they are misleading you. The cells are either not live or not FDA approved (which requires Section 351 Registration.)
In total, there are a few very FDA approved live stem cell products and these are only allowed for restricted use such as for bone marrow transplantation in severe end-stage cancer etc. The full list of FDA approved products is here.
None of the FDA approved live cell products are live Umbilical Cord products or live Amniotic or live Placenta products or Exosomes and none of the approved live cell products are allowed for musculoskeletal or orthopedic use.
The 351 cell-drug designation is a long, complex, and extremely expensive process. It can take hundreds of millions of dollars and 5–10 years of clinical trials to get a real FDA approval. If their product fails clinical tests, they won’t get approval. There is no FDA approved live amniotic or live cord blood product with an orthopedic indication on the market today. (So if a chiropractor, doctor or sales rep tells you that they have one, beware, it’s not true.)
All new drugs that are licensed by the FDA go through an FDA application process called an IND which stands for Investigational New Drug Application or an NDA which stands for New Drug Application. Since our procedures fall under Section 361, we do not need to register them as a new drug and so we do not need an FDA drug application (IND or NDA.)
Institutional Review Boards oversee clinical trials for new FDA drug applications. Since our procedures do not require an FDA drug application, we do not require an Institutional Review Board (IRB).
We only use your own stem cells (Autologous Stem Cells) which we use carefully under Section 361 of the Public Health Service Act.
Yes, according to a recent study1 “it is feasible to obtain large numbers of high-quality autologous (your own) MSCs (Mesenchymal Stem Cells) from the elderly population.”
1. Restoring the quantity and quality of elderly human mesenchymal stem cells for autologous cell-based therapies. Block TJ, Marinkovic M, Tran ON, Gonzalez AO, Marshall A, Dean DD, Chen XD, Stem Cell Res Ther. 2017 Oct 27;8(1):239. doi: 10.1186/s13287-017-0688-x. Link to Article
Autologous Stem Cells are your own stem cells and allowed by the FDA under Section 361.
Allogeneic Stem Cells are stem cells from another human being. They are severely restricted by the FDA and must go through a complex costly Section 351 “cell drug” registration. Currently, there are no live FDA approved Umbilical Cord or Amniotic or Placental stem cell products.
The claim of live cells from another person. The FDA regulation says at 21 CFR 1271.1 at section 4 part 2 that if you claim that your cells are alive and have metabolic activity and they’re a donor tissue (from one person to another) that’s considered a drug so can’t go through the 361 tissue-registration system. It requires a 351 cell drug designation for FDA approval.
Note that it’s simply the claim of live cells that makes the difference. The cells may really be dead and all that exists is the manufacturer claiming that they’re alive, but the claim is enough to trigger the regulation.
The 351 cell-drug designation is a long, complex, and extremely expensive process. It can take hundreds of millions of dollars and 5–10 years of clinical trials to get a real FDA approval. If their product fails clinical tests they won’t get approval. So the simple online 361 tissue registration and clever wording is a better fit to their bottom line.
The upshot? There is no FDA approved live amniotic or live cord blood product with an orthopedic indication on the market today. So if a chiropractor, doctor or sales rep tells you that they have one, beware, it’s not true.
Illegal product + FDA approved lab = illegal product.
If umbilical cord or amniotic stem cells are “made” or processed in an FDA or CLIA approved lab, they are still an illegal product.
Exosomes are a product of lab cultured mesenchymal stem cells. According to recent FDA correspondence, Exosome products are 351 biologics and need a full 351 cell drug registration.
No Exosomes or exosome product have current FDA approval.
Yes, write, call or email the FDA yourself and find out:
Center for Biologics Evaluation and Research (CBER)
Office of Communications, Outreach and Development
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Tel: (800) 835-4709
OCOD@fda.hhs.gov
600 Worcester Rd, Ste 301,
Framingham, MA 01702
This information is for educational purposes only and is NOT intended to replace the care or advice given by your physician. Always seek the advice of your physician or other qualified health provider before starting any new treatment or with any questions you may have regarding a medical condition. For more information see our Medical Disclaimer.
