COVID-19 UPDATE: Regenexx is committed to the health and safety of our patients. You may now be seen in clinic or via telemedicine for virtual/online or phone visits.
LEARN MORE
Our physicians are available via telemedicine to continue to give you the care you need during this difficult time. Learn more.

American CryoStem Review 2: Busted for Expanding Stem Cells

By /

Receive a Regenexx® Patient Info Packet by email and learn why it's a superior regenerative solution.

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.

A while back I warned about a company called American CryoStem (ACS) and physicians who were holding a seminar on how fat cells could be collected and culture expanded. You see, this was clearly illegal, but the physician network (who put on the seminar) claimed it was all under an Institutional Review Board (IRB), so it was legal. Turns out I was right, as ACS just received a Warning Letter from the FDA. Let’s review the issues.

What Is Culture Expansion?

Culture expansion means growing cells to bigger numbers in an ideal environment. This can be done with fat or bone marrow stem cells, and it’s what we began doing in the U.S. way back in 2005. However, eventually, we learned that the FDA considered this a prescription drug without approval (despite this being the patient’s own stem cells), and we fought a long legal battle to determine if this was within the scope of the practice of medicine or needed FDA approval. Eventually, the courts sided with the FDA, so we licensed a site in Grand Cayman where this was allowed and only continued in the U.S. with stem cell preparations that the FDA thought were not a drug.

Here are a few interesting articles about our ordeal:

What Is American CryoStem?

I first learned about ACS when a colleague was sent an e-mail from the Cell Surgical Network (CSN). This is a group of physicians using fat-based stem cells. Regrettably, the FDA has recently made it clear that stem cells isolated from fat (called stromal vascular fraction, or SVF) are a drug and can’t be created in a physician’s office. This is despite the network claiming otherwise.

Last January, CSN claimed that they could offer stem cells culture expanded by ACS to their patients under an IRB-approved study. I was shocked as I knew all culture expansion of cells was considered a drug by the FDA that would require approval for each medical indication. Given that the company was offering cells for many medical indications, not even Pfizer could support that many FDA studies. In addition, the company had no biologics license to allow a clinical trial to permit the use of these cells.

The Recent FDA Action

Scott Gottlieb’s FDA has been stating that it will aggressively pursue “bad actors” who are violating FDA rules. Since then there has been a steady stream of FDA actions with the most recent this week against ACS. The FDA stated that its Atcell product, which is culture expanded, is a drug without any FDA approval or license that would allow a clinical trial (what’s called a BLA, or Biologics License Application). The company also had many violations of cGMP drug manufacturing processes, which is not surprising as this site likely uses the much lower processing standard of cGTP, which would be more consistent with processing transplant tissues.

What would posses Cell Surgical Network and ACS to believe that the FDA would allow them to culture expand cells? The ruse was that this would be allowed under an “IRB.” An Instutional Review Board is an organization that can oversee studies, but in this case you would also need a BLA from the FDA to start the research. Hence, none of their position ever made any regulatory sense.

The upshot? You just can’t make this stuff up. It looks like the FDA is making good on its promise to take down stem cell therapy bad actors. I’m sure we’ll see more actions in the coming months.

Category: Latest News

Leave a Reply

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

2 thoughts on “American CryoStem Review 2: Busted for Expanding Stem Cells

  1. Diane Fay

    I have a question
    I had a right hip replacement 5/2017..before I had it done. I really tried everything i could to avoid that…starting with…..Prolotherapy..I visited 5 Ortho MD’s in Chicago,they recommended R Hip Replacement…again…I went searching ..tried a Regenexx clinic in Chicago, and your clinic in Broomfield….and everything helped…
    but not enough to take away the pain..I never went the cortisone route…oh, also had PT for a long time…massage etc etc…acupuncture..
    I finally met an Ortho Dr. in Knoxville,TN…who ..supported me in my love of running…when the others told me my running days were over..
    He said…He never tells his patients…to stop what they love doing..
    so ..i am running…made it to state… in Senior Olympics…and regionals are in June…I was wondering…if PRP or Stem Cells could help strengthen my R leg…esp my R knee, r ankle…??
    I love what you do and believe in your commitments to health and sports…esp when we age…I am 70 years old..

    1. Regenexx Team

      Diane,
      Great story – love to see you make it! I’d give Nashville Regenerative Orthopedics a call, as they could likely help. Please see: https://nashvilleregenerative.com

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

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

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

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

Subscribe to the Blog

CONTACT US

9035 Wadsworth Pkwy #1000
Westminster, CO 80021
888-525-3005

FOLLOW US

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.

LinkedIn
Email