I’m sitting here on a plane on my way back from Grand Cayman after having a full weekend of procedures with my patients. I’m grateful to have their trust and to be able to help them get back to doing what they love to do.
One of my patients was Dr. Josh Axe, who has graciously given us permission to use his name.
He stated: “I want to thank Dr. James Leiber and Regenexx for their incredible care. I have noticed a significant improvement in the low back pain I was experiencing from an injury. This is an ideal alternative to drugs or surgery with no side effects and what I believe to be 10x better results.”
Like Dr Axe and 80% of the population, I had occasional low back pain that was at times debilitating for days to weeks at a time. Five years ago, it was just getting worse and worse and impacting my ability to do almost anything. Working was difficult, exercising was limited, and playing with my daughter was a chore.
Forget about housework and home improvement projects …
That’s when I decided to try one of the procedures that I had been performing on my own patients. I chose to have 3 of my lumbar discs injected with large quantities of my own stem cells to help heal the tears that were seen on the back of the discs on the MRI.
After I recovered, I went from daily chronic pain with frequent severe episodes to virtually no pain for the last 5 years, allowing me to return to the active lifestyle that I had previously been accustomed to.
FDA Regulations
For years now, we’ve been affiliated with Regenexx Cayman, where there are expanded options for highly-skilled, image-guided, injection-based procedures to help with orthopedic and spine-related conditions that are not available in the United States.
In the U.S, the FDA regulates how body tissues are used. This is a big topic with a lot of fine detail. For a deeper dive, see my talk on FDA regulations.
Briefly, to summarize, utilizing one’s own bone marrow concentrate (containing mesenchymal stem cells) and platelet-rich plasma (containing growth factors), in the same patient, on the same day, with minimal laboratory manipulation, is exempt from FDA regulations.
However, certain things change how this tissue would be classified and thereby regulated.
One example is if the tissue is used for a purpose that is considered non-homologous (that is, in a way that is thought to be inconsistent with how the body would normally use it). In this case, the tissue/cells are no longer regulated as a body tissue, in a sense, and are instead regulated more similarly to a manufactured drug compound requiring years of studies and millions, if not billions of dollars in drug trials before being approved.
Additionally, if the tissue/cells are more than “minimally manipulated”, then it would also be regulated as a drug. Several steps in laboratory cross the line into more than minimal manipulation. One example would be if the stem cells are isolated from the bone marrow (or adipose/fat tissue) and grown in a laboratory to higher quantities. This process is referred to as culture-expansion. This process, from a regulatory standpoint, changes how the cells are classified. They are no longer seen as one’s own cells but rather as a manufactured drug requiring all the same steps that any drug would require to be approved.
This regulatory framework is meant to offer a way to keep the public safe, but it also, unfortunately, sets a very high bar of proof and a massive financial burden to get that approval. It is outside of the reach of physicians and is only feasible to pharmaceutical companies who are incentivized to label a patient’s body tissue/cells as a marketable mass-produced drug able to re-coup the research and development costs and time required to get that approval.
For culture-expanded mesenchymal stem cells, there has yet to be an approved “product” in the United States for orthopedic use. Despite this, there has been considerable research and experience in using a patient’s own cells, grown in culture, for that same patient. To date, studies are very promising in terms of outcomes and safety, and clinical experience has, likewise, been quite encouraging.
So, How Does Regenexx Cayman fit into all of this?
In Grand Cayman, the laws allow for the process of culture-expanding one’s own stem cells for storage and for injection later. The laboratory at Regenexx Cayman is one of the most sophisticated and experienced in the world when it comes to storing and growing mesenchymal stem cells for orthopedic and spine clinical use for the last 11 years.
At New Regeneration Orthopedics, we have been affiliated with Regenexx Cayman for over 5 years, performing these sophisticated procedures for patients in that facility and are amongst a small number of Regenexx physicians nationally that are licensed in Cayman to work there.
The procedure is Grand Cayman is referred to as Regenexx-C.
What Conditions Respond to Regenexx-C Procedures?
The answer is simple: All the same orthopedic and spine-related conditions that we typically see in U.S. using Regenexx procedures containing bone marrow concentrate and/or platelet rich plasma (PRP).
Take a look at this graphic, showing the various conditions we can treat.
In particular, we’ve been quite impressed with the results associated with injections in the lumbar discs for patients suffering from disc-related low back pain.
What are the possible advantages to using Culture-Expanded Mesenchymal Stem Cells (MSCs)?
- Larger quantities, from 100-1000 times the baseline levels of MSCs found in the same-day bone marrow concentrate procedures.
- The option of storing cells at your current age to be utilized at a later time, when you are older.
- The ability to have one bone marrow harvest/draw that can result in enough cells to treat many body areas at the same time and still possibly have left over cells that can used later, without the need for an additional harvesting procedure.
- The ability to grow the cells in a way that favors a specific type of orthopedic tissue.
What is the process?
The first step is to have a consultation with one of our physicians who is licensed in Grand Cayman, either via telehealth or in-person.
Once an evaluation has been completed, options are discussed, and it has been determined that you are a potential candidate for a Regenexx-C procedure, it’s time to plan and coordinate the next steps.
If you choose to just have your cells stored for future use, it would require one trip to Cayman to have the bone marrow harvested.
However, if you are looking to have a procedure on one or more body areas, the procedure would require two trips to Grand Cayman.
The first would be to meet one of our physicians at the facility to have a bone marrow draw. This is a safe and minimally uncomfortable procedure. You can then go enjoy Grand Cayman with minimal restrictions and head home when you’re ready.
In the meantime, the laboratory will isolate your cells, test their genetics to make sure they are healthy enough to grow and be used, then grow them to large quantities over a period of 4-6 weeks. At that point, they are cryopreserved at your current age until you are ready to go back to Cayman to have them injected precisely back into the regions of your body that need strengthening and/or healing.
The first few days afterward result in some pain and swelling. Improvements in your levels of pain and your function occur over time, usually taking from 6-12 weeks or more before starting to see the beginning of improvement which continues to get better over the ensuing months and probably doesn’t peak and plateau for over a year. We would expect the improvement to be sustained for years and for some conditions, we would recommend maintenance of that improvement with periodic PRP procedures.
To find out if you are a candidate for a Regenexx Cayman procedure, contact us today.
