Dr. Centeno is currently on his two-week stint treating some of his patients at the Regenexx Cayman facility (something he does a few times a year), so we thought this would be a good time to update you on this licensed and advanced cell-culture site and its state-of-the-art lab. This summer, the facility moved and underwent a lab expansion, and now their lab is larger than ours here in our Colorado clinic. So what exactly do we do in Grand Cayman, and why do we take some of our patients down there?
Some Patients Just Need More Cells
For the overwhelming majority of our patients, the same-day bone marrow stem cell treatments here in our Colorado clinic are plenty sufficient for their orthopedic conditions. These treatments involve aspirating the patient’s bone marrow, concentrating and isolating the stem cells in our lab, and then injecting those stem cells the same day. A few of our more extreme cases, however, just need more cells than the same-day treatment can accomplish, and, unfortunately, in the U.S. we (and all physicians) are limited in the types of cell treatments we can provide. At the Grand Cayman advanced cell-culture site, we can culture expand these cells, growing them to much greater numbers. And more cells means higher doses to work with in our patients who need more cells. So why can’t we do this in Colorado and the U.S.?
While our procedure is in phase-2 FDA clinical trials here in the U.S., culturing cells for clinical use is currently not FDA approved in the U.S. as the FDA considers them a cell drug. In Grand Cayman, however, this procedure is considered the practice of medicine, so we are able to offer this treatment to our patients at a site licensed by a local company. For a lot more information on what we do in Grand Cayman, please watch Dr. Centeno’s video (note: this was filmed at the old facility before this summer’s move and expansion):
The Grand Cayman Cell-Culture Facility Gets an Upgrade
When the site in Grand Cayman first began, the lab consisted of a prefab clean room enclosed in glass and housed in a back area of a diagnostic lab. The setup worked, but the area was small and the site soon outgrew it. Our licensee (Phillip Ebanks, Harmonic Health), therefore, decided a facility move was in order.
This would be a major financial commitment, but it would allow Ebanks and the lab manager (Chase Demarest) to totally customize and redesign the facility to accommodate both workload and workflow. The result (see current image below)? The Caribbean’s largest clean-room cell-processing lab:
- 3,400 sq ft
- Six biologic safety cabinets
- Two -150C freezers, including liquid-nitrogen jacket back-ups
- Two -80C freezers
- Four -20C freezers
- Eight incubators
Nothing else in the Caribbean even compares to Regenexx Cayman. The Bahamas has a cell therapy site, but it has no lab facilities and instead uses a small automated machine to make SVF from fat. Mexico does cell therapy as well; however, the largest company there utilizes a cell-manufacturing facility in Houston. The Regenexx Cayman clean room cell-culture facility is truly one of a kind.
The World’s Most Advanced Orthobiologic Therapies Are Happening in Grand Cayman
We’ve been using stem cells to treat a variety of orthopedic conditions longer than any other clinic on earth. Dr. Centeno pioneered orthopedic stem cell treatment and the field of interventional orthopedics. He has plenty to keep him busy right here in Colorado, so why does he make the journey to Grand Cayman for a few weeks every year (as do some of our other physicians who are licensed in Cayman)? The world’s most advanced orthobiologic therapies are happening in Grand Cayman, thanks to the Regenexx Cayman state-of-the-art advanced cell-culturing lab, and we don’t want to limit stem cell therapy to same-day treatments in our patients who need more-advanced therapies!
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.