Across the country, there are thousands of stem cell clinics offering procedures for treating musculoskeletal injuries, osteoarthritis, and other conditions. A good majority of them conduct procedures using only autologous material. That is important because the use of minimally-manipulated autologous material is that which allows them to operate without further FDA approval.
So what is so special about autologous stem cells? The answer to that question and more is discussed in this post. Suffice it to say that doctors who maintain stem cell procedures in compliance with current FDA regulations can utilize autologous material in a safe way that poses very little risk to patients.
Definition of Autologous Material
By its nature, medicine deals with all sorts of biological material including blood, skin, and so forth. The term ‘autologous material’ is very specific to that kind of biological material donated by the person being treated. So let’s say you visit your doctor to receive stem cell injections for osteoarthritis in your knee. If he extracts those stem cells from your blood or fat tissue, he is extracting autologous material.
This understanding of autologous material is critically important to the regenerative medicine debate. A typical stem cell procedure utilizing autologous material is extremely safe for the simple fact that patients are being treated with their own stem cells. They are not being treated with cells taken from strangers. Thus, there is no risk of rejection and very little risk of complications.
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But What About…
Perhaps you are ready to object based on some of the stories you’ve read in the news. For example, maybe you have heard about all those people made sick by contaminated stem cell products shipped to clinics in Florida, Texas, and Arizona. Do not just assume. Read all of the details.
The fact that those clinics were using stem cell products obtained from a third party clearly means they were not using autologous material. In addition, those stem cell products contained more than just stem cells. They also contained additional substances added by the provider. This is a clear violation of FDA regulations.
The provider was issued a warning letter and instructed to cease providing products not in compliance with the rules. If they do continue anyway, we can only assume the FDA will go after them even more aggressively.
Not Appropriate for Every Condition
You might also remember the stories of the three women from Florida who were blinded after being treated for macular degeneration via stem cell injections. Again, do not just assume those three cases prove that stem cell injections are bad across the board. Read the details.
Stem cells taken from fat tissue or blood are very specific kinds of cells. They are mesenchymal stem cells that can only differentiate into the same types of tissue from which they are extracted. As such, they are not appropriate for macular degeneration. The procedures never should have been performed to begin with.
Apex Biologix, a Utah company that supplies doctors and medical clinics with regenerative medicine equipment and supplies, is quick to remind consumers that stem cell injections are not appropriate for every condition. They are absolutely correct.
We still have a long way to go before we fully understand the mechanisms behind what stem cells do. For now, the number of applications for which stem cell treatments are appropriate is very limited. They are limited to procedures in which autologous stem cells can be extracted, processed, and injected into the site of injury or disease in order to promote healing. Anything outside of autologous mesenchymal treatments is not yet ready for prime time.