Stem Cell FAQs:

Umbilical Cord Blood

Currently, there are no live FDA Approved Umbilical Cord Products.

Using live cord or live  amniotic stem cells from another person or placenta is considered a “cell-drug” by the FDA and requires a full drug approval process.

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 and none of the approved live cell products are allowed for orthopedic use.

Watch our Medical Director discuss  Umbilical Cord Stem Cells:

Janet D Pearl FDA
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Live stem cells are allowed by the FDA under 2 registrations

Live stem cells are allowed by the FDA under 2 registrations: Sections 351 and 361 of the Public Health Service Act 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. 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 products. If any provider or company that claims to use “FDA approved” live cord or live amniotic cells they are misleading you. The cells are either not live (Section 361) or not FDA approved (which requires Section 351 Registration.)

If live:

  • Not Approved: have not undergone required FDA 351 safety testing for live cells (“cell-drug” designation)
  • Not Matched: There is a real risk of disease from the donor baby or rejection reaction (GvH, HvG immune reaction)

May Not Be Live: When they are delivered to the patient, cells may be dead (false advertising)
Be cautious of providers who offer untested and unapproved products!

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 and requires a full 351 cell drug designation for FDA approval.

Stem cells and the FDA

Your own Cells are better

Using your own stem cells are safe. There is no risk at all of of an immune reactions (such as graft Vs. host or host Vs. graft).  They are live Stem Cells and give you all the advantages of live stem cells and their use is allowed by the FDA (within outlined criteria). Here, at the Boston Stem Cell Center, we use your own Stem Cells.

A recent study* showed that your own Stem Cells are more effective than umbilical cord stem cells. This is thought to to due to the fact that your own stem cells are safe and do not cause any immune reaction, while umbilical cord calls are believed to always cause some level of immune reaction.

*Combating Osteoarthritis through Stem Cell Therapies by Rejuvenating Cartilage: A Review, Stem Cells International; Volume 2018, Article ID 5421019

In December 2018, twelve people in three states developed infections and were hospitalized after they got infusions or injections of stem cell products derived from umbilical cord blood that were contaminated. Click here for the CNN Article for more details.

A recent investigation of “live” amniotic cell products at Cornell University looked at 11 “live” amniotic cell products. They concluded that there were no actual living cells and low growth factor levels in all the “live” amniotic cell products they looked at. Click here for a YouTube discussion of the investigation.

FAQ's

FDA FAQ's

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. 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.

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

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