Live cells are allowed by the FDA under Certain Circumstances
Live 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 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.
We use products and perform therapies cleared for general use by the United States Food and Drug Administration, but specific indications for treatment have not be evaluated and reviewed by the FDA. You are encouraged to consult with your primary care physician prior to undergoing a cell therapy.
351 : cell-drug approval:
complex and expensive registration
Our Procedures Fall Under
Section 361 (and/or The Same Day Surgical Exception)
To our knowledge, 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 or Amniosomes and none of the approved live cell products are allowed for orthopedic use.
The 351 Approval Process
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 a product fails clinical tests, it won’t get approval. To our knowledge, 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.)
NDA, IND and IRB’s
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 (and/or the same day surgical exception), 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.
FAQ's
FDA FAQ's
We only use your cells (Autologous Cells) which we use carefully under Section 361 of the Public Health Service Act or the same day surgical exception.
No. We do not harvest or use any embryonic stem cells. Aside from the ethical considerations, this is not permitted in the US.
We only use your own cells (Autologous Cells) which we use carefully under Section 361 of the Public Health Service Act or the same day surgical exception.
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 Cells are your own cells and allowed by the FDA under Section 361 and/or the same day surgical exception.
Allogeneic Cells are 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.
We do not culture cells or use any cultured cells.
There are some centers, which recommend taking the stem cells from the bone marrow and growing them in a laboratory and then injecting them back into a patient. The FDA has ruled that cultured cells cannot be used in the United States.
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.
We do not offer any exosome or live cord products since they are not approved by the FDA. We only offer autologous products which we offer within the FDA Section 361 guidelines (and/or the same day surgical exception.)
Exosomes are a product of lab cultured mesenchymal stem cells. According to recent FDA correspondence, Exosome or Amniosome products are 351 biologics and need a full 351 cell drug registration.
No Exosomes, amniosome or exosome product have current FDA approval.
We do not use Collagenase (or any enzymes) or Stromal Vascular Fraction (SVF) in any of our procedures since we believe that these are not permitted by the FDA.
ENJOY LIFE AGAIN WITHOUT JOINT PAIN OR SURGERY
Find out if you are eligible for our treatments.
Is Orthobiological Cell Treatment Right For You?
Although Orthobiologic Treatments are considered by some people to be experimental, various research studies show that cellular therapy and platelet rich plasma injections may provide excellent relief from joint and musculoskeletal pain and ongoing inflammation.
