Are Amniotic and Umbilical Cord Treatments “FDA Approved”?

by Chris Centeno, MD /

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fda approved umbilical cord blood

The explosion in birth tissue use where mostly alternative health practitioners use dead amniotic and umbilical cord products and claim to be injecting millions of young stem cells has been fascinating to watch. One of the questions we get all the time is caused by clinics offering these treatments claiming that they are “FDA Approved”. Is this true? Nope, not even close. So what gives?

Amniotic and Umbilical Cord Scams

As I have blogged many times before, these commercially available birth tissues being used by providers contain no live mesenchymal stem cells. This is based on research by our lab, CSU, UC Irvine, and Cornell. This is often very different than what you see advertised out there. Watch my video below or follow the links for more information:

Here’s another video of a podcast by Lisa Fortier from Cornell on this topic:

What are Amniotic and Umbilical Cord Products?

These are products that are sold by US companies that bottle various birth tissues after processing. These include the outer sac that the baby lives in (amnion), the fluid that surrounds the baby (amniotic fluid), the blood in the umbilical cord, and the tissue in the umbilical cord (typically Wharton’s Jelly). While these issues, when taken from a live birth and walked down to a lab in the same hospital or campus and placed into culture will have some stem cells, the commercial products being sold do not. Why? The way these tissues are sourced, usually from public hospitals, is one reason. Meaning, they tend to sit around. Next up is that they then need to be transported to a processing facility and again wait on a processor. Then they are processed (cut, ground, squeezed, withdrawn, digested, etc…) and bottled. Finally, they are frozen and stored and then shipped someplace and shock thawed by the provider before use. So after this torture test, the cells die.

The Clinic that Said These Were Live Stem Cells Has a Certificate that Says They Are Alive!

The problem is that these certificates or white papers that come from manufacturers have too little information to prove what they’re claiming. Hence, only a third to half of the tests that would need to be done to show live stem cells were actually alive are ever completed. See my video below for more details:

Are Amniotic and Umbilical Cord Products FDA Approved?

If you’re a visual person and want a video, I’ve already done one on this topic:

So are these products FDA approved? No, they are definitely not FDA approved. While many clinics advertise this because they don’t understand the FDA approval vs. registration process, this is a false statement. Why? FDA approval means that the FDA has reviewed the product which has gone through extensive clinical trials per medical use. So that’s one FDA approval for knee arthritis, a separate one for hip arthritis, and yet another for shoulder pain. NONE of these companies that produce these tissues have this type of FDA approval.

So what do they have? They have completed a 45-minute free online registration that allows FDA to know where they live and what’s being sold. That’s it. FDA has reviewed nothing. FDA has approved nothing. No clinical trials have been completed. No approval has been granted. FDA has not even inspected the lab where these tissues are processed prior to the registration.

The FDA Warning on Umbilical Cord Stem Cells

The FDA has a warning about umbilical cord stem cell scams right on its website. They state that there is no FDA approval for any such product outside of pediatric cancer care. Hence, there is no FDA approved umbilical cord product for arthritis, spinal problems, or tendon tears. This is despite what orthopedic sales reps and clinics state.

So Let’s Review a Totally Fictional Facebook Post

Now that you’ve learned a bit, let’s look at this Facebook post:

First is the statement that FDA regulates cord blood by making sure there is 85% viability. FALSE. The only FDA involvement here is that the manufacturer of the cord blood filled out a free registration form on-line that asked where the company is located and what they’re selling. That form asks no data about viability nor does the FDA regulate nor test viability.

Second, we have tested the viability of many different umbilical cord products as have others. None of them out the bottle had viability anywhere close to 93%. What’s also not said here is critical, as most of these products have viabilities out of the bottle in the 40-60% range, but all of these cells that test as “alive” right away, die within hours. Meaning, they are alive and quite damaged.

Third, the cells duplicate for 65 cycles! The cells are quite dead or dying, which means that they don’t replicate at all. In fact, this number seems to be identical to a FAQ produced by umbilical cord vendor Liveyon. I have already blogged on this product, Liveyon PURE. Where did they get this number? My guess is that it’s sourced from a study on cells taken directly from the womb and thrown into culture.

The upshot? Now you know that amniotic or umbilical cord cells are not FDA approved. In fact, FDA has a warning on their website about this issue. In addition, hopefully, you now understand that anybody claiming to be selling you a stem cell treatment with living amniotic or umbilical cord stem cells is running a scam.

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Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
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