What To Know About Umbilical Cord "Stem Cell" Products
Updated: Sep 30
Samuel G Oltman, ND, RMSK
"Get your fresh pure stem cells here!" you can read and hear when you go searching online for solutions to joint pain. They say that "young cells" are better, they say that the products are "pure", they say umbilical cells are more active than the cells in your own body. The problem is that none of this is true and that none of it is legal.
Fetal-tissue-derived products that are marketed as Wharton's jelly, amniotic fluid, umbilical cord stem cells, etc are not what they say they are. They say they are "stem cell therapy" but there is little reason to believe there are any living cells in them. They are a manufactured product that is not regulated and are outright illegal.
There is unlikely to be any living stem cells
Studies on various fetal tissue products show that very little can actually grow out of these products (1). This means there aren't viable, living cells. There may be beneficial growth factors, cytokines, or helpful cellular fragments but there aren't living cells. Some clinics offer these products but do not market them as "stem cells" and that is much more accurate and less deceptive, but the product is still illegal. The basic selling point that these products contain "young, pure cells" is simply untrue.
There is plenty of anecdotal evidence of patients being helped by these products. This can be attributed to many other things other than viable stem cells, such as anti-inflammatory growth factors contained in the product. But even if this is the case, it's not stem cell therapy and patients ultimately aren't getting what they're paying for.
Think about the supply chain for these products: They are harvested from planned c-section donors, sterilized, freeze dried, powderized, stored on liquid nitrogen, sold to a clinic, shipped across the country, kept in storage at the clinic, re-hydrated for treatment, then injected into a joint. There is not much living at the end of the process and very little that can actually grow, multiply, and act like a stem cell.
They operate within a loophole that is not real
The loophole is usually said to be for research purposes under a "section 361 exemption". They say the product is FDA registered, but that is a sleight of hand that does not mean approval or legality. FDA registration only requires filling out a form online. The most common reason for the illegality is that these products do not meet the "homologous use" criteria.
The FDA has sent out and continues to send out cease and desist letters to clinics and manufacturers that offer these therapies. The legal standing is clearly spelled out on their website: these are unapproved drug products.
Here are some of the FDA cease and desist letters:
There are some stem cell products with FDA clearance for studies that are regulated as a biologic product, like this (2). These bear little resemblance to the products being used in clinics for joint pain. If you're not enrolled in a study and getting treatment at no cost to you, you're not getting a regulated/legitimate product.
What is happening at clinics outside of the US?
There are clinics outside the US that are able to utilize cultured stem cell products where stem cells are grown in a petri dish to increase the total cell count. There is also more leeway with how and where these cells are administered. This is due to large differences in the regulatory environment.
There are also clinics in these countries that have piggy-backed on the medical tourism and are simply using the same low-quality fetal tissue products described above. Just because the clinic is outside the US doesn't mean they are using high-quality cultured products. The general lack of oversight and quality assurance is a concern.
Is there any way to utilize stem cells in the US?
Fat and bone marrow are two legitimate and legal sources of stem cells in adults. Neither method produces pure stem cells and are therefore not referred to as "stem cell therapy". These are "autologous" methods where the cells come from the patient's own body. Read more about this subject here.
There is a good chance that some type of fetal tissue product is the future of medical care for osteoarthritis and joint pain. The theoretical basis is there and it is promising. But as it stands now, patients are not getting what they think they are. The practice simply has not caught up to the theory.
There is a lot of misinformation out there. It is hard to parse for patients and physicians alike. The FDA, over multiple presidential administrations, has been very clear about where these things stand and it's not a gray zone: umbilical cord and related fetal tissue products are illegal (and don't have viable cells in them anyway). There are good options for joint pain that can be utilized here in the US, contact us today to see if you're a good candidate.
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