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Grand Cayman Opens Larger, State of the Art Cell Manufacturing Lab

POSTED ON IN Latest News 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. 

    *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.

    comments

    DavefromLA says

    Looks like a nice expansion! Can you please elaborate on what Phase-2 clinical trials with the FDA means for the future re: the generation of greater numbers of stem cells for more serious orthopedic afflictions, i.e., if this and subsequent Phases are successful, will these more advanced SC procedures be available in the U.S. rather than just offshore, and what kind of rough timetable can we expect? And could this perhaps lead to insurance companies ultimately "accepting" and paying for these procedures? Thanks and enjoy the sunsets...

    replies

    Regenexx Team says

    DavefromLA,

    Yes, if approved, we could use cultured stem cells in the US. Timeframes are always tough to nail with FDA approval processes, but 3-5 years would be reasonable.

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    DavefromLA says

    Thank you. I'm learning so much about medical procedures and how our medical system works (and doesn't) from your blogging -- much, much more informative than the popular press which does a miserable job on this topic.

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    Susan Ross says

    Is the cost less for the procedure in the Cayman Island?

    replies

    Regenexx Team says

    Susan,
    No, it's not.

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    Jackie Parket says

    I opted to receive stem cells in my knee rather then a total knee replacement about three years ago. I was given no guarantees on the success rate as I had almost no cartilage left. Results were about 90% less pain and I was more then satisfied. I am now experiencing pain once again. Do I have any options now other then the dreaded knee replacement?

    replies

    Regenexx Team says

    Jackie,
    We'd be glad to take a look to see what's going on.

    replies

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    About the Author

    Chris Centeno

    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.…

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