Stem Cell ‘Clinics’ and the Okyanos Difference
Oct 2, 2015
Original Article: http://okyanos.com/adult-stem-cell-therapy/the-okyanos-cell-therapy-difference/
When I co-founded Okyanos it was—all fancy words aside—with the purpose of using cell therapy to help chronically ill patients return to a more normal life. Inherent in that has been the goal to “do it right,” meaning provide the highest standard of care to patients who are in pain or otherwise suffering. There is a lot that goes into doing it right but more on that in a moment; first, I want to highlight a concern:
Adult stem cell therapy promises to be the next phase in the evolution of medicine. It is almost unfathomable the potential number of patients that may benefit from the use of their own biology to address unmet needs. Along with that, as would be expected in any emerging field with vast opportunity for financial gain and personal recognition, there is a spectrum of participants: from the predatory to the sincere but not necessarily qualified, to the competent but not well-equipped and so on up to the quality of care we aspire to give. Yet, it being such a new field, patients have no easy way of really assessing where the various providers fit in the spectrum of quality cell therapy care.
To get to the point, recently there have been articles both positive and negative about U.S. stem cell clinics doing “patient-funded” research for $8900 per treatment—that’s the base price, by the way. The doctors providing these treatments have, for the most part, been to a weekend stem cell course and use a Korean device called a Lipokit. The doctor selling (and using) the device states in a recent interview that the output is a “soup” and he doesn’t know what is in it but if there are stem cells in there the patient will benefit. Perhaps he is being loose with his language—or not—but either way this isn’t confidence-inspiring.
To be fair and balanced, we hear reports that some patients are benefiting, we just don’t know how many, how much or for how long, because despite the fact that this “research” was started in 2010 and is now being done by about 100 doctors across the U.S., we are not aware of one publication to date documenting the outcomes and doubt many of the doctors even report results to the “principal investigators.” If you are running a study you need to keep follow-up data; it’s that simple.
Okyanos Cell Therapy Delivers Up to 50x More of Your Cells
The fact is some serious researchers do know what is in the Lipokit “soup” and how it compares to other systems. It came in 3rd place out of 4 in a side-by-side comparison study done at Cedars-Sinai in Los Angeles by Dr. Joel Aronowitz et al. Their study found that the Celution System used by Okyanos yields on average 7x the amount of viable stem and regenerative cells per gram of adipose tissue as the Lipokit. (Pictured below: The Cytori Celution System, photo courtesy of Cytori Therapeutics.)
In addition, the Celution device can process 425 ccs of fat vs. a maximum of 100 ccs with Lipokit. In actuality, some of the doctors charging $8900 only process less than 100 ccs, so if you do the math it is possible you are getting up to 50x more stem and regenerative cells than Lipokit. That is a big difference! And because the Lipokit is not fully automated, operator variability enters in, which circles back to the comment that the doctor doesn’t know what is in the soup. It can be very confusing, however, because many of these stem cell ‘clinics’ promote the idea that patient is getting 100 million cells or more. This is not entirely untrue, but they are including in their count not just the active reparative cells but all cells based on inferior counting technology. Ouch!
The above-referenced study is the best source for separating the wheat from the chaf—or, said another way, the stem cells from the debris. These U.S. stem cell clinics probably fit into the category of a sincere, somewhat competent, but definitely ill-equipped group of “stemcellologists.”
Okyanos Cell Therapy Cell Processing Technicians separate millions of adipose stem cells from patients’ own adipose tissue for same-day use in treatment.
We have built our cell therapy center of excellence, standards of service and world-class team around substantial scientific research and clinical experience that shows cell therapy to be safe and potentially beneficial for the indications we treat. We accept only patients we truly feel can be helped with our treatment. It is this level of dedication to responsible medicine with oversight and guidance from some of the world’s leading cell therapy researchers and medical professionals which set us apart.
Like many things, cell therapy is a two-way street—you get back what you put in. All that we have put into Okyanos is to give you the patient, the greatest opportunity for a better quality of life.
Putting Your Cells to Work Using the Celution® and Lipogems® Systems
Okyanos Cell Therapy combines both IV infusion of the cells with direct injection to treat the underlying systemic cause as well as the affected site respectively. For this dual approach, we use two different cell processing technologies—both approved for use across the EU and Asia including countries such as Japan, China, Australia, Singapore and others:
Cytori Celution System – Used for IV infusion and cardiac procedures.
Lipogems System – Used for direct injection to joints, chronic wounds, etc.
The Cytori Celution device produces about 25 million cells for every 100 CCs per the Aronowitz paper resulting in the potential to yield over 100 million therapeutic cells from the patient assuming 425 ccs were available to process. (There is variability on a patient-by-patient basis.) TheLipogems system is used in addition for patients who require joint and other direct injections. This cell processing system produces a “biological paste” with the cells, allowing them to engraft or “stick to” the affected area. Using Lipogems, the cells have the opportunity to do their primary job of regeneration for a much longer period of time. (Pictured below: Lipogems System, photo courtesy of Lipogems International.)
Ensuring Safety and Success
On August 7, 2013, The Bahamian Parliament passed legislation allowing and regulating the use of patients’ own stem cells for treatment. Okyanos is fully licensed to operate by the National Stem Cell Ethics Committee (NSEC) of The Bahamas, and we are regulated under the Stem Cell Research and Therapy Act of 2013
The Bahamas Ministry of Health oversees the following criteria are in place before granting a license:
Stem cell therapy protocols must have substantial scientific and clinical trial data supporting its safety.
Healthcare facilities providing the treatment must have cellular Good Manufacturing Practices (cGMP) in its lab as well as the customary and usual requirements for a surgery center or clinic.
These criteria are roughly on par with those that were adopted in 2014 by the Japan Ministry of Health.
Your Cells, Your Health—Our Mission
Combining state-of-the art technologies delivered in the first cell therapy center of excellence in the world, Okyanos truly has the best potential to deliver a therapeutic benefit. Our patients are cared for at our state-of-the-art surgery center with hospital-level care and nursing staff.
There are many stem cell ‘clinics’ that claim to have their own proprietary methods of separating stem cells. The issue is that without scientific research and clinical trials it is anyone’s guess what the patient is getting and whether it has worked before.
Okyanos’ protocols are supported by substantial literature, key clinical trials and case reports. We have put a tremendous amount of effort and resources into bringing stem cell therapy to our patients at the highest possible standards of safety, delivery and care.
After all, only if you return to a more normal life are we then a success.
Oct 2, 2015
Original Article: http://okyanos.com/adult-stem-cell-therapy/the-okyanos-cell-therapy-difference/
When I co-founded Okyanos it was—all fancy words aside—with the purpose of using cell therapy to help chronically ill patients return to a more normal life. Inherent in that has been the goal to “do it right,” meaning provide the highest standard of care to patients who are in pain or otherwise suffering. There is a lot that goes into doing it right but more on that in a moment; first, I want to highlight a concern:
Adult stem cell therapy promises to be the next phase in the evolution of medicine. It is almost unfathomable the potential number of patients that may benefit from the use of their own biology to address unmet needs. Along with that, as would be expected in any emerging field with vast opportunity for financial gain and personal recognition, there is a spectrum of participants: from the predatory to the sincere but not necessarily qualified, to the competent but not well-equipped and so on up to the quality of care we aspire to give. Yet, it being such a new field, patients have no easy way of really assessing where the various providers fit in the spectrum of quality cell therapy care.
To get to the point, recently there have been articles both positive and negative about U.S. stem cell clinics doing “patient-funded” research for $8900 per treatment—that’s the base price, by the way. The doctors providing these treatments have, for the most part, been to a weekend stem cell course and use a Korean device called a Lipokit. The doctor selling (and using) the device states in a recent interview that the output is a “soup” and he doesn’t know what is in it but if there are stem cells in there the patient will benefit. Perhaps he is being loose with his language—or not—but either way this isn’t confidence-inspiring.
To be fair and balanced, we hear reports that some patients are benefiting, we just don’t know how many, how much or for how long, because despite the fact that this “research” was started in 2010 and is now being done by about 100 doctors across the U.S., we are not aware of one publication to date documenting the outcomes and doubt many of the doctors even report results to the “principal investigators.” If you are running a study you need to keep follow-up data; it’s that simple.
Okyanos Cell Therapy Delivers Up to 50x More of Your Cells
The fact is some serious researchers do know what is in the Lipokit “soup” and how it compares to other systems. It came in 3rd place out of 4 in a side-by-side comparison study done at Cedars-Sinai in Los Angeles by Dr. Joel Aronowitz et al. Their study found that the Celution System used by Okyanos yields on average 7x the amount of viable stem and regenerative cells per gram of adipose tissue as the Lipokit. (Pictured below: The Cytori Celution System, photo courtesy of Cytori Therapeutics.)
In addition, the Celution device can process 425 ccs of fat vs. a maximum of 100 ccs with Lipokit. In actuality, some of the doctors charging $8900 only process less than 100 ccs, so if you do the math it is possible you are getting up to 50x more stem and regenerative cells than Lipokit. That is a big difference! And because the Lipokit is not fully automated, operator variability enters in, which circles back to the comment that the doctor doesn’t know what is in the soup. It can be very confusing, however, because many of these stem cell ‘clinics’ promote the idea that patient is getting 100 million cells or more. This is not entirely untrue, but they are including in their count not just the active reparative cells but all cells based on inferior counting technology. Ouch!
The above-referenced study is the best source for separating the wheat from the chaf—or, said another way, the stem cells from the debris. These U.S. stem cell clinics probably fit into the category of a sincere, somewhat competent, but definitely ill-equipped group of “stemcellologists.”
Okyanos Cell Therapy Cell Processing Technicians separate millions of adipose stem cells from patients’ own adipose tissue for same-day use in treatment.
We have built our cell therapy center of excellence, standards of service and world-class team around substantial scientific research and clinical experience that shows cell therapy to be safe and potentially beneficial for the indications we treat. We accept only patients we truly feel can be helped with our treatment. It is this level of dedication to responsible medicine with oversight and guidance from some of the world’s leading cell therapy researchers and medical professionals which set us apart.
Like many things, cell therapy is a two-way street—you get back what you put in. All that we have put into Okyanos is to give you the patient, the greatest opportunity for a better quality of life.
Putting Your Cells to Work Using the Celution® and Lipogems® Systems
Okyanos Cell Therapy combines both IV infusion of the cells with direct injection to treat the underlying systemic cause as well as the affected site respectively. For this dual approach, we use two different cell processing technologies—both approved for use across the EU and Asia including countries such as Japan, China, Australia, Singapore and others:
Cytori Celution System – Used for IV infusion and cardiac procedures.
Lipogems System – Used for direct injection to joints, chronic wounds, etc.
The Cytori Celution device produces about 25 million cells for every 100 CCs per the Aronowitz paper resulting in the potential to yield over 100 million therapeutic cells from the patient assuming 425 ccs were available to process. (There is variability on a patient-by-patient basis.) TheLipogems system is used in addition for patients who require joint and other direct injections. This cell processing system produces a “biological paste” with the cells, allowing them to engraft or “stick to” the affected area. Using Lipogems, the cells have the opportunity to do their primary job of regeneration for a much longer period of time. (Pictured below: Lipogems System, photo courtesy of Lipogems International.)
Ensuring Safety and Success
On August 7, 2013, The Bahamian Parliament passed legislation allowing and regulating the use of patients’ own stem cells for treatment. Okyanos is fully licensed to operate by the National Stem Cell Ethics Committee (NSEC) of The Bahamas, and we are regulated under the Stem Cell Research and Therapy Act of 2013
The Bahamas Ministry of Health oversees the following criteria are in place before granting a license:
Stem cell therapy protocols must have substantial scientific and clinical trial data supporting its safety.
Healthcare facilities providing the treatment must have cellular Good Manufacturing Practices (cGMP) in its lab as well as the customary and usual requirements for a surgery center or clinic.
These criteria are roughly on par with those that were adopted in 2014 by the Japan Ministry of Health.
Your Cells, Your Health—Our Mission
Combining state-of-the art technologies delivered in the first cell therapy center of excellence in the world, Okyanos truly has the best potential to deliver a therapeutic benefit. Our patients are cared for at our state-of-the-art surgery center with hospital-level care and nursing staff.
There are many stem cell ‘clinics’ that claim to have their own proprietary methods of separating stem cells. The issue is that without scientific research and clinical trials it is anyone’s guess what the patient is getting and whether it has worked before.
Okyanos’ protocols are supported by substantial literature, key clinical trials and case reports. We have put a tremendous amount of effort and resources into bringing stem cell therapy to our patients at the highest possible standards of safety, delivery and care.
After all, only if you return to a more normal life are we then a success.