Are Amniotic and Cord “Stem Cell” Products FDA Approved?

By /

This is an installment in our continuing series on amniotic and cord “stem cell” products. Today, I’d like to look at stem cell regulations to see whether these products are FDA approved as some claim, or fall into an entirely different category. As you’ll see, there is no approval pathway for these dead tissues, but instead a simple online registration. However, that can all change if a manufacturer begins to claim that there are live cells (whether or not that’s true).

Amniotic and Cord Blood “Stem Cells” Defined

Amniotic fluid is the fluid inside the sac a baby lives in while in its mother’s womb. Amniotic membrane makes up the sac itself. You might see the term placenta used as well, and this is where that sac attaches to the mother’s uterine wall. Amniotic fluid and membrane do contain, for example, some beneficial growth factors, extracellular matrix proteins, and collagen. And amniotic and placental tissues (fluid and membrane) collected after birth have been used for a century or more in some medical procedures (e.g., in eye or spinal-cord procedures).

One thing that products that are made from amniotic fluid and membrane do not contain, however, is usable stem cells. Let me explain. Fresh from delivery, these tissues do contain some stem cells; however, amniotic fluid is not a stem cell product because once the fluid is processed (concentrated, freeze-dried, chopped up, packaged, cryopreserved, etc. and then shock thawed) for use, no viable, or living, stem cells remain. We know this because we have tested amniotic “stem cell” products ourselves as has the Interventional Orthopedics Foundation. If we could obtain viable, healthy stem cells from amniotic fluid, we would be using it.

When you see the term cord, or cord blood, stem cells, this structure refers to the umbilical cord that connects mother and baby. The cord contains a vein and two arteries, which is where we find cord blood. These vessels are supported inside the cord by the Wharton’s jelly. The majority of stem cells in the cord are found in the Wharton’s jelly, not, generally the cord blood. But, again, once processed, we have not been able to find any viable, or living, stem cells that remain in the cord blood.

Stem Cell Regulations: Are Amniotic and Cord “Stem Cells” FDA Approved?

Many pushing these amniotic and cord “stem cell” products claim that they have a stamp of approval from the FDA, so are these products FDA approved?

In the world of stem cell regulations, there are two entirely different FDA pathways for donor tissues. One is the simple 361 registration, and the other is the complex 351 cell-drug approval. All of the orthopedic and amniotic and cord blood products on the market today have the simple 361 registration, which, unlike a drug approval, requires no clinical trials or data.

So what’s so simple about getting a 361 tissue registration? According to the information on the form, It takes about forty-five minutes of your time to complete and submit such a registration. If you watch the video above, I show you the actual form. You just answer who you are and where they can find you and check a few boxes about what you’re registering, and that’s it.

So what determines if the 351 cell-drug approval is needed? The claim of live cells (see the FDA regulation in the video above). 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, that’s considered a drug, and you can’t go through the 361 tissue-registration system; it requires a 351 cell drug designation for FDA approval. Also, note that it’s simply the claim that makes the difference. The cells may really be dead and all that exists is the manufacturer of the amniotic and cord stem cell products claims that they’re alive, but the claim is enough to trigger the regulation.

So why aren’t these companies following stem cell regulations and just getting the proper 351 FDA approval instead of playing word games with their marketing? 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. 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 amniotic or cord blood product with an orthopedic indication on the market today. So if a doctor or sales rep tells you that they have one, beware, it’s not true. In addition, as a doctor, if you’re using a misbranded drug that you know is misbranded, you may be in just as much hot water as the manufacturer!

Get health and wellness information from a trusted source.

By submitting the form, you are agreeing that you read and consent to our Privacy Policy. We may also contact you via email, phone, and other electronic means to communicate information about our products and services. We do not sell, or share your information to third party vendors.

Category: Latest News

Leave a Reply

Your email address will not be published. Required fields are marked *

5 thoughts on “Are Amniotic and Cord “Stem Cell” Products FDA Approved?

  1. Audrey Harrell

    Just curious, you guys have tested product from the amniotic sac and amniotic fluid, as well as cord blood. Have you tested any product derived directly from the Wharton’s jelly? Or is this not a product that currently exists? Or do you expect that the cryopreservation of this product would have the same effect? Thanks for your feedback.

    1. Chris Centeno Post author

      We would expect the same issues with viability in a Wharton’s Jelly product.

    2. Regenexx Team Post author

      We’ve not aware of a product commercially available derived from Wharton’s Jelly to test.

  2. TD

    So these claims, testimonials, and procedures done are fakes? I don’t understand. Whom can we trust? We need help NOW.

    1. Regenexx Team Post author

      The claims of FDA approval for the use these products are being used for is False. The claims that there are live and viable stem cells in these products is False.

Is Regenexx Right For You?

Request a free Regenexx Info Packet


Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar


Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog


9035 Wadsworth Pkwy #1000
Westminster, CO 80021


Copyright © Regenexx 2020. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.