It’s spring, and again I’m down at our licensed advanced-practice site in Grand Cayman. As you can see above, it’s beautiful down here. That was last night at sunset from the back porch.
The U.S. only allows stem cells to be isolated and used in the same surgical procedure in which they’re taken. However, stem cells can be grown to greater numbers over a few weeks. If there are extra, they can also be saved in cryopreservation for future use.
The patients I see here in Cayman tend to fall into one, or both, of two categories. The first is that they have multiple sites to be treated. The second is that they have a diagnosis that doesn’t respond well to same-day stem cells. Let me explain.
Some patients have multiple problem areas. For example, they may have arthritis in both knees and a shoulder rotator cuff tear. Because, unlike other clinics, we know that we need a minimum dose of stem cells to treat each knee and that most older patients won’t hit a high enough dose with a same-day stem cell procedure, growing the stem cells to bigger numbers may be a good option.
The other situation when cultured stem cells may be the best choice is a diagnosis that doesn’t respond well to same-day stem cells. While we can treat most problems with a same-day stem cell procedure, a few things need more cells. For example, anything more than mild hip arthritis may require cultured cells.
All of our national network providers have the option of getting licensed to practice medicine in Grand Cayman and bringing their patients to this licensed advanced-practice site. So this is not exclusive to Colorado providers. Ask your local Regenexx provider if he or she can offer cultured stem cells as an option.
While the USFDA has been quite clear that culturing stem cells in the U.S. is not legal without a drug approval, that hasn’t stopped at least two US-based groups from floating that risk. These take two forms: the fake stem cell study and the “self-serve” approach. Let me explain.
I’ve covered one of these cultured-stem-cell businesses on this blog. This group states that they are running a clinical study. However, when you look under the covers, they don’t have the proper FDA approvals for this type of drug research. The other is what I call the “self-serve” approach. This means that there is no faux study, but a doctor will offer to take your fat and will provide the name of a place that can isolate and culture the stem cells. This bizarre attempt at circumventing FDA regulations involves the patient taking their fat sample to the lab and picking up their cultured cells. The idea is that since the patient is the one who is requesting that his or her cells are cultured and stored (and not the doctor), then this is legal. It’s not really, but it is an enchanting fairy tale.
So what can happen to your stored cells when either one or both of these scams are busted by the feds? Your cells are an illegal drug product. They can’t be used by you in any way. Also, they can’t be sent out of the U.S. because that would be the export of an illegal drug product. The money you’ve paid is, therefore, wasted.
The upshot? I love coming down to Grand Cayman. For me it’s great to have options as a licensed physician in the Caymans. Now, all Regenexx network doctors can do the same. Finally, beware of US clinics claiming they can enroll you in a pay-for-play clinical trial or that you need to take your cells to and from a lab for culturing. You might just end up paying a bunch of money only to have your cells lost forever!
The Regenexx-C procedure is not approved by the USFDA and is only offered in countries via license where culture-expanded autologous cells are permitted via local regulations.
*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…