Grand Cayman Opens Larger, State of the Art Cell Manufacturing Lab
POSTED ON IN Research BY Chris Centeno
I'm blogging from the Caymans again, having just started my two weeks here seeing patients at our licensed advanced cell culture site. This site just completed a huge clean room expansion and moved their lab into these more spacious digs. They now have a larger lab facility than our Colorado site.
What Is Culture Expansion?
While the vast majority of our patients do fine with same-day stem cell procedures where cells are just isolated and put back in right away, a few need more cells than this process can generate. For these patients, we can grow cells to greater numbers in culture. This process is undergoing phase-2 clinical trials with the FDA in the U.S., but we use it clinically in Grand Cayman at a site licensed by a local company. That's because the procedure is allowed here under the practice of medicine. For more info on what we do here in Cayman, please see my video below (filmed at the old facility):
The New Culture Facility
When the Grand Cayman site began, the lab was a glass-enclosed prefab clean room dropped into the back part of a diagnostic lab. This worked well, but the site quickly outgrew this small area. As a result, our licensee (Phillip Ebanks with Harmonic Health) decided to move the facility. Doing that was a huge financial commitment and also allowed the lab manager (Chase Demarest) and him to work with a blank slate to totally redesign the facility and workflow. At 3,400 sq ft, with 6 biologic safety cabinets, 2 X -150C freezers with liquid nitrogen jacket back-ups, 2 X -80 C freezers, 4 x -20C freezers, and 8 incubators, this is now the largest clean room cell-processing lab in the Caribbean. While there is a cell therapy center in the Bahamas, they use a small bedside machine to create SVF and don't have lab facilities. In addition, while cell therapy happens in Mexico, the cell manufacturing facilities for the largest company operates out of Houston. Hence, this is a big achievement to have this type of clean room cell-culture facility sitting on a small first-world island in the Caribbean.
Why Do I Come Down Here 3 Times a Year for 6 weeks?
I have a very busy practice back home in Colorado. In fact, since I've been using stem cells to treat common orthopedic problems longer than anyone else on earth, I have more patients than I can reasonably see. So why uproot my life three times a year and lengthen my waiting list to make the pilgrimage to Grand Cayman? This is where the world's most advanced orthobiologic therapies happen. Any leader in the field worth his or her salt would be down here in a heartbeat.
Network Physicians in Cayman
We now have many different network physicians around the country who bring their patients down here. This is one of the privileges of being on our provider network. Unlike banana republic clinics that also culture expand, US physicians can get licensed in Cayman. Hence, they can perform the procedure rather than turfing it out to a lesser-trained local yocal doctor. The upshot? The sunsets and the lab are amazing! Two weeks on island time should be a nice change of pace for me. In the meantime, this is where the world's most sophisticated interventional orthopedics and orthobiologics happen, in a great big lab on a tiny Caribbean island known more for its banking and hedge funds than its biotechnology sector! 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.
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