The above notification was sent out by the FDA on Dec 20, 2018. A few months ago, I wrote a blog on umbilical and cord bold stem cell products. The blog message was for one to exercise caution with these products. Basically, what I said was buyer beware. What I included was an email from the FDA concerning these products. The bottom line of the blog was that these products did not contain stem cells or if they did it would be in violation of FDA since they did not have the proper licenses. In this case, these products were registered as a 361 with the FDA which is a fairly easy straight forward registration. However, 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. Yet these companies have continued to try to sell the public on these products as complying with the regulations. Well, it appears the chickens have come home to roost!
On Dec. 20 the FDA issued a letter concerning these products. The letter was issued to one company but I think it can be implied that this letter was is a guidance from the FDA to companies processing placenta and amniotic products. There certainly are some companies that this will not pertain to since they seem to be in full FDA compliance. But typically, these companies make no claims about live cells. They state they have only growth factors but they contain no living cells.
One serious aspect that the FDA mentions in its letter is the fact that bacterial contamination was found in the products that Genetech (the manufacturer) and Liveyon (the distributor) were distributing. This is a very serious matter. In any procedure there is a chance of an infection. However, when we are starting with an infected product than we are truly behind the eight ball. Unfortunately, a number of patients became infected when using these products. Apparently, some unopened vials were also found to be contaminated according to various reports so one cannot blame the clinics where the injections were given.
Granted an infected product by a manufacture is a very serious problem, however the FDA in their warning letter raised some other very serious concerns. The following is from the FDA letter:
“In the case of Genetech, the FDA inspected the company’s facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The Genetech products are not intended for homologous use (products that are intended for the same function in the recipient as the donor), and while the products have a systemic effect, they are not intended for allogeneic (genetically similar) use in a first or second-degree blood relative. As such, the products are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.”
Let us look further at what the FDA said in its letter. They were concerned 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 perhaps is of even more concern is the fact that the FDA states that since the placenta products have a systemic effect that they then require a biologics license to be marketed. It goes on to say that if a biologics license is not obtained then it will be necessary to obtain an Investigational New Drug application (IND) before the product can be used in humans. The FDA further states that neither of these licenses have been obtained. 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 have these registered as what is called a 361 which means that it is a tissue product only. Some of these companies are correct in that their product is a tissue product (basically growth factors) only. However, there are a number of companies that are registered as a 361 but claim live cells with metabolic activity. With the claim of live cells these companies have crossed the line and become a 351 as was pointed in the FDA letter. The problem is that they lack either a biologics license or an IND. To reiterate what the FDA says about a 351: “To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect”.
The bottom line is that if you are told you are being given a “stem cell procedure” using either a placenta or amniotic product than 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.