29 Oct Do Umbilical Cord and Amniotic Tissue Have Live Stem Cells?
Over the past decade, the use of allograft tissue in regenerative therapies has continued to exponentially increase. These have included post natal tissues that consist of donated umbilical cords, amniotic fluid and possibly the placenta. The reason is that these tissues have produced exceptional results for patients and to date have been very safe.
When a practice advertises “stem cell therapy”, the assumption is that the biologic used in the procedure will contain stem cells. Live stem cells, actually. So the question becomes, “Does allograft tissue such as umbilical cord and amniotic fluid contain live stem cells?”
The answer to that question is YES, and possibly NO. Let me explain. When allograft tissue is first obtained from consenting donors after a scheduled c-section, there are millions of live stem cells in the tissue. Of course those stem cells are critical to the development of the growing baby along with a significant amount of cytokines, growth factors, exosomes, microRNA and additional cells and proteins.
The reason I mention both “YES” and “NO” regarding live stem cells is because of what may or may not happen at the lab performing the processing of the tissue. While the FDA stringently regulates how birth tissue is processed, there are significant variations in how labs perform the tasks.
For instance, some labs use radiation to sterilize the tissue. Others do not. Some labs use a significant amounts of reagents and preservatives which may affect the viability of the cells. Others do not.
While there are several companies who state that umbilical and amniotic tissue biologics are not “allowed” to have live stem cells, this is NOT the case. All that rhetoric comes from competing companies in the bone marrow and adipose space, who are actually afraid of the fact that post natal tissue procedures are dwarfing their existence.
The regulations from the FDA that pertain to biologics do not exclude the existence of live cells. There are plenty of labs in the US who are very careful with the processing of post natal biologics. They do not use radiation, minimal reagents and preservative are used, and at the end of processing the biologics are carefully cryopreserved.
The cryopreservation process is similar to how egg donor embryos are frozen and does NOT kill the cells. That process was delineated decades ago! So the naysayers who stipulate that none of these products have live cells because it’s either not allowed, or the processing kills them are typically just plain wrong and attempting to further an agenda.
Now there are a LOT of labs in the US that do kill the stem cells with their processing techniques. So that is why the answer includes both a YES and NO component.
So how to tell the difference? Testing by the lab itself helps, but obviously there can be some bias involved. So testing from an accredited third party is unbiased, and has shown unequivocally from many labs that there ARE in fact, live stem cells in biologics.
In fact, we have seen many of these third party tests showing live mesenchymal stem cells present. This is confirmed by surface markers that are specific to live stem cells. How is that not validation? It’s indisputable.
Now I have seen competitors who supposedly obtain the products and then get them tested at a “certified” lab. However, as it turns out, the competitor actually owns the lab and is able to manipulate the testing.
How can that be done? Well if the product is thawed out and then allowed to sit for 6 hours that will affect viability. Also if the biologic is drawn up from a 27 guage needle that will lyse the cells. So those tests have been manipulated and simply performed to mudsling against the allograft companies who are taking away business year after year.
In conclusion, the answer to the question is that if a post natal biologic is carefully processed, without radiation and significant preservatives, and then carefully cryopreserved, then live stem cells will be present. In large numbers, typically.