Autologous Stem Cells: Do They Belong to You?
An interesting aspect of the stem cell therapy market as it stands today is that autologous stem cell therapies are regulated by the U.S. Food and Drug Administration (FDA) as a “drug.”
Stem cells, such as hematopoietic stem cells that have been used for decades in bone marrow transplants, can be extracted from an individual, and on the same day, can be re-injected into a specific site that needs repair. When the cells are sourced from and implanted into the same person this is called an autologous transplant.
Regenexx Stem Cell Procedure
One of the most well-known of these approaches is the Regenexx procedure. You’ll have a very difficult time finding negative press about the procedure from patients, despite that many patients have paid several thousand dollars “out-of-pocket” to access the care, as it is typically not covered by health insurance carriers in the United States.
The reason is that the results are often outstanding. I am an example of a patient whose life was transformed by the procedure. I’m currently taking action to get access to my own “before” and “after” MRI of my knee damage that was addressed through stem cell regeneration. I have my before MRI, but am in the process of acquiring my post-treatment MRI, as I just reach my one-year anniversary of the transplant.
In the meantime, here is a before and after MRI of another patient’s knee showing positive clinical results from the Regenexx procedure:
How Regulation of Autologous Stem Cell Procedures Affects the Global Stem Cell Market
As a stem cell research firm, the question that interests me most (and the question that will interest most of our readers who are executives at stem cell companies or stem cell industry investors) is how will the current regulation of autologous stem cells as a “drug” affect the broader stem cell marketplace?
If regulations in the United States that treat autologous stem cell as a drug do not change, then other countries, most notably Japan and Canada, but also United Kingdom, Australia, and others, will soon outpace the U.S. in this area of medicine.
Furthermore, for-profit companies in the U.S. will not have financial incentives to invest in the development of autologous stem cell treatments.
For the stem cell market at large, continued regulation of autologous stem cells as drugs within the United States will cause more money to flow overseas, followed by more jobs, more talent, and more research advances. Without regulatory change, the epicenter of the stem cell market will not be the United States. Japan is moving forward rapidly with stem cell based cellular therapy development, and in many respects, has already out-paced the U.S.
Are Stem Cells Different from Current Surgical Tissue Grafts?
When considering autologous stem cell regulation, an important question to ask is whether the use of autologous stem cells for therapeutic purposes should be considered as substantially different from current procedures. For instance, in many surgical procedures, including traditional approaches to ACL repair, a graft is taken from another site of a patient’s body and placed into a different part of the body. One of the best-known examples of this is an approach for anterior cruciate ligament ( ACL) reconstruction that removes part of a patient’s hamstring tendon for use as a new ACL “substitute.” This procedure is known as Hamstring Tendon Graft Reconstruction (HTGR).
This comparison raises the question, are stem cells that have originated in you a “drug,” or do you and your doctor have a right to use them for therapeutic purposes, as surgeons have done for decades?
“Special” and “Designer” Stem Cells
Naturally, there are different types of stem cells, and some come with greater complications and risks than others. For instance, there might be greater value in the regulation of stem cells that are sourced from another individual, a procedure known as an “allogenic” stem cell transplant. (“Allogenic” means coming from another.)
There are also embryonic stem cells (ESCs), which must be derived from embryos at fertility clinics. Note that the same embryos used to derive ESCs would be discarded or eventually die if they were not used to derive ESCs, because embryos cannot be indefinitely preserved. It is no more possible for an embryo to life indefinitely than it is for a human being to live forever.
There are also induced pluripotent stem cells (iPSC), which are adult cells that are reverse engineered to be pluripotent in nature, allowing them to have the potential to become a diverse range of adult cell types. Functionally, they are quite similar to embryonic stem cells in their therapeutic potential.
However, these “special” and “designer” stem cell types must not be compared to the basic hematopoietic stem cells that travel throughout an adult body, highly concentrated in specific regions such as the bone marrow. These autologous stem cells are intrinsic to every living being.
For that reason, I leave you today’s powerful quote, not as an answer, but as fuel for intellectual curiosity:
Enjoy, comment, and get in on this discussion of how autologous (“self”) stem cells should or should not be regulated!
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BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of market research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking.
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