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).