A few months ago, I wrote a blog on umbilical cord blood and placenta stem cell products being made available in the US. The central message was to exercise caution with these products, applying the principle of caveat emptor [buyer beware].
The bottom line message of the blog was that these products did not contain live stem cells. If they did, it would be in violation of FDA rules since they did not have the proper licenses. These products were registered as a 361 with the FDA which is a fairly easy straightforward registration. By contrast, if there are live cells with metabolic activity then the product becomes a 351 which requires a biologics license or, at minimum, an investigational new drug application [IND]. Yet, there are companies continuing to try to sell the public on these products as complying with FDA regulations and, at the same time containing live stem cells.
On December 20, 2018, the FDA issued a letter concerning these products. One serious element of the letter was that bacterial contamination was found in products manufactured by Genetech and distributed by Liveyon. Apparently, according to various reports, some unopened vials were found to be contaminated and a number of patients became infected following their use. To its credit, in September 2018, Liveyon suspended shipment of all product pending an inquiry into the source of the adverse reactions and possible contamination. Liveyon also voluntarily recalled all Genetech products it may have distributed.
In addition to the serious problem of a manufacturer’s infected product, the FDA letter raised a number of other serious concerns as set out in the following extract:
Let us look further at the meaning of some of these issues. There were concerns expressed about non-homologous use of the product. What this means is that, if the cells are found in placenta tissue, they can be injected into another body only if they can function as placenta tissue in that body. Obviously, a joint is not the same as placenta tissue. The cells have now taken on a different function. So, placenta tissue into a joint is not a homologous use.
What is perhaps of even more concern is that, since the placenta products have a systemic effect, they then require a biologics license to be marketed. Alternatively, an Investigational New Drug application (IND) will be needed before the product can be used in humans on a clinical trial basis. To the best of my knowledge I am not aware of any major company selling these placenta products that has obtained either of these licenses.
Be aware that there are companies involved with placenta products registered as what is called a 361 which means that it is a tissue product only. Some of these companies are correctly describing their products as tissue products (basically growth factors) only. However, there are other companies with products registered as a 361 but claiming them to contain live cells with metabolic activity. With the claim of live cells, if true, these companies have crossed the line and become a 351. Alternatively, the claims are false.
The bottom line is that, if you are told you are being given a “stem cell procedure” using either a placenta, cord blood or amniotic product, then ask the physician what he is basing this on and if the product has the proper licensing. The bottom line is BUYER BEWARE! You may not be getting what you think.
To demonstrate the risk of what you could get, consider carefully the following abstract from a letter received from the Florida Department of Health, dated February 22, 2019.
Dear: Dr. Purita,
The Florida Department of Health (Florida Health) is working with the Centers for Disease Control and Prevention (CDC) on an investigation of bacterial infections linked to contamination of an umbilical cord blood-derived stem cell product from the ReGen Series (distributed by Liveyon, LLC). You may already be aware of Liveyon’s recall of this product issued on September 28, 2018
The CDC and the U.S. Food and Drug Administration (FDA) have received reports of patients developing bacterial infections of the joints, bloodstream, or spine, among others, after receiving the ReGen Series products. Additionally, an inspection of the processing facility by the FDA identified deviations in the requirements for processing these products, and for the testing and screening of the umbilical cord blood donors for these products for the following communicable diseases:
We are not currently aware of any HIV, hepatitis B, or hepatitis C infections linked to the ReGen Series products and transmission risk is very low. However, Florida Health is requesting that you notify all of your patients who received this product that they should consider being tested for HIV, hepatitis B virus, hepatitis C virus, and possibly for the other infections listed above after discussion with their health care providers. A template letter is available for your use to notify patients and can be provided upon request.
If you believe you have a patient who has had a bacterial or other infection related to the administration of this product, please notify the Health Care-Associated Infection Prevention Program at 850-245-4401 or email Danielle.Rankin@flhealth.gov. If you have any questions about talking to your patients or anything else regarding this letter, please do not hesitate to contact us.
Russell W. Eggert, MD, MPH, FACPM, FAAFP
Bureau of Epidemiology
REMEMBER, YOUR OWN CELLS DO NOT POSE A RISK OF THESE DISEASES UNLESS YOU ALREADY HAVE THEM!
Thanks, Dr. Purita.
Date March 20, 2019