Installment 88 - Ask the CEO/Matthew Feshbach/Okyanos/September 2016
About Matthew Feshbach
Matthew Feshbach is CEO and co-founder of Okyanos, which helps patients with chronic, degenerative diseases return to a more normal life using adult stem cell therapy.
Prior to the creation of Okyanos, Matt's career as an investor spanned more than 30 years. His initial interest in the potential of stem cells began in 2009 when a financial partner introduced both Matt and his twin brother, Joe, to the field of personalized medicine and cell biology. Extensive research led Matt to believe that adult stem cell therapy could provide an answer to many of the largest unmet healthcare needs in the Western world.
The vision for Okyanos was borne out of this initial research. Along with his brother and Manuel Vianna, Matt founded Okyanos to provide adult stem cell therapy to those with coronary artery disease and severe heart disease and congestive heart failure who had exhausted all available options from the currently available standards of care. With a strong foundation of supporting clinical research and approval from the Bahamian Government to perform cell therapy procedures, the Okyanos Cell Therapy protocol was later expanded to include a number of other chronic conditions treatable with patients' own stem and regenerative cells.
After helping to create Okyanos, Matt's brother Joe sadly and ironically died of a heart attack in 2011. Joe's death prompted Matt to an even more diligent effort to provide a new standard of care for patients with heart disease and other debilitating conditions. Okyanos began treating patients in 2014 at their state-of-the-art facility located in Freeport, Grand Bahama.
Matt's focus remains on uncompromising commitment to quality of patient care. Through research and operational excellence, Okyanos was built to provide patients with a new option-backed by robust science and rigorous clinical research when they have exhausted all other options.
Maximizing the potential benefits to patients, their families and to society is the singular focus of Matt and his team.
North American Office
1150 Cleveland Street, Suite 201
Clearwater, FL 33755
Local Tel: 727-290-4780
Questions & Answers
Q: Matthew, I have been following your path for 5 years and have nothing but utmost respect for you. I have been invested in Cytori and other stem cell stocks for a long time. I have seen the hard path you have chosen, but to be honest I did not think the path would be this long or difficult.
This therapy works on so many levels for so many indications. Clinical data up to Phase 3 is there to back up the efficacy. It is proven safe, in my opinion. My question is... and sorry it is so open ended... Do you see your clinic contributing to earlier adoption of this new healthcare paradigm?
A: It has been a very “interesting” path as per your introduction. The Okyanos (oh-key-ah-nos) vision really revolves around creating autologous cell therapy as a new category in healthcare and being the leading provider in it.
When I co-founded Okyanos, it evolved out of the same sense of frustration with the U.S regulatory environment that so many patients with complex chronic diseases have. As I had invested in Cytori Therapeutics, I saw that despite over $200M (and now over $350M) of investment, international approvals for their Celution device and more than 5,000 safely treated patients, they could not get off first base with regulatory approvals here at home. I was incredibly impressed with the results from their small but rigorous cardiac cell therapy trials in particular but thought it would be at least 5 years for them to get approval and bring that urgently needed therapy to patients. I was wrong by at least 5 years and believe that is the case for virtually all cardiac cell therapy approvals.
Thus, Okyanos was founded on several guiding principles:
1. Following surgery, drugs and devices, cell therapy would be the next phase in the evolution of medicine, and someone needed to set the standard and create a trusted brand.
2. To bring this therapy to patients now, it should be done “right.” By that I mean development of a standard of care and safety that equals or exceeds US surgical center standards.
3. We wanted to locate ourselves in a jurisdiction that was regulated and legislated so the standards we aspired to would also be required of others. In other words, we wanted to be certain patients could trust the cell product that was being delivered to them, the medical team, the protocols, the facility and the technology.
Q: Would it be possible for your clinic to keep a record of the safety and efficacy of adipose cell therapy on your patients?
A: We do and in fact, as part of the licensure in the Bahamas, we contribute our data to their national stem cell registry. The Bahamas National Stem Cell Ethics Committee (NSCEC) is co-chaired by Dr. Glen Beneby, Chief Medical Officer of the Bahamas and Dr. Joshua Hare, the Director of the Interdisciplinary Stem Cell Institute at the University of Miami. The NSCEC takes their duty to protect patients and advance the science quite seriously, as does Okyanos.
Q:What are your suggestions to patients and caregivers to make these therapies more quickly available to residents of the USA and Canada?
A: Unfortunately, the regulatory environment in the U.S. is a bit strange. On one hand the FDA has made it incredibly clear that stem cells from your own body, particularly fat (adipose) derived stem cells, are considered a drug and so to be administered to patients must go through a full phase 3 FDA trial process. Unapproved drugs can’t be randomly prescribed as “practice of medicine” in the U.S., Europe or other developed countries, despite the insistence they can.
On the other hand, they don’t always enforce these regulations, and so there are hundreds of clinics onshore marketing stromal vascular fraction (SVF) treatments—but not at a standard that provides consistent and remarkable outcomes from a single treatment that is seen when clinical Good Manufacturing Practices (cGMP) of the cell preparation is required, as is the case in the Bahamas.
I think advocacy groups such as Stem Cell Pioneers are key to changing the regulatory environment, but unfortunately I think it will get worse before it gets better. The new FDA commissioner, Dr. Rob Califf, strongly believes in “evidence-based” medicine as defined by large phase 3 blinded, randomized trials. This standard seems extreme for re-infusing a person’s own cells to treat damaged or diseased tissues and organs. The same cells that are in the fat (adipose) tissue are in a person’s blood stream, skin and bone marrow, etc. If these cells were harmful we would all be “dead on arrival.” They are in fact the repair cells that keep us alive. From a safety perspective there is nothing to prove assuming cGMP cell processing technology is used and the procedure is done in a sterile environment with qualified physicians.
From an efficacy perspective, these adult stem and regenerative cells are “repair cells” that lie quiescently in the inner linings of our blood vessels and are released to home to areas of inflammation. In other words—of course they work. We would all be dead at a young age if they didn’t. Think of how many times children bump and bruise themselves to get up and play a few minutes later. If this happened when we were middle-aged, we would be in the ER.
In other words, the only problem with stem cells in our blood stream, bone marrow and other tissues is that they deplete and lose potency with age. Adding to that, diseases like diabetes, heart attacks as well as smoking adversely affect the potency of bone marrow stem cells. We believe that bone marrow stem cells are safe and efficacious but use them when you are young. Fortunately, the stem and regenerative cells in our adipose tissue or what we call adipose-derived stem and regenerative cells (ADRCs) are uniquely protected. As a result, they are accessible, abundant and potent even late in life. I highly recommend that students of the adult stem cell game read “Buying New Soul” by Dr. James Willerson and Dr. Emerson Perin of Texas Heart institute. They are preeminent researchers in the field and don’t have a vested interest in one cell source or type over another as they don’t have commercial interests as providers of UBCs, BMCs, placental stem cells (PSCs) or SVF have.
Q: Are all doses of SVF created equal?
A: Cell processing devices from Korea and “convenience kits” sold to doctors online just don’t yield many therapeutic (nucleated) cells per the literature in the former case, and in the latter case there is no documentation that we have found.
We use the Celution system which has been documented to have at least a 7x higher yield per gram and with some recent protocol refinements we have been able to produce double that yield on average. We can process up to 425 ccs of fat vs the standard 60 ccs seen in clinics. Our average dose is about 77 million nucleated cells.
Importantly, no one has really reported what is in the “soup” that domestic providers deliver, and there is operator variability when a semi-automated system is used. When you see claims of 100 million stem cells on 60 ccs of tissue, patients should know that the cells are not being counted with a Nucleocounter but rather a device such as the Moxi-flow, which is set to count all the particles. This is an extremely misleading practice and is one more reason regulators will likely enforce market discipline.
Q: Since many lung disease patients also have heart problems, is there such a thing as a treatment(s) that would benefit both conditions?
A: We have a protocol that includes direct injection into the wall of the heart as well as IV of cells. As is well known, when cells are placed in the blood stream via IV the first organ they reach is the lungs. We now accept patients on oxygen as long as they can travel safely.
Q: I read your website information about treatment for MS. Wouldn't it take multiple treatments to really show significant long term benefits? Are the cells expanded?
A:If one reviews the trials that use fresh ADRCs from a cGMP device such as Celution for autoimmune conditions, one thing that stands out is that patients are seeing a continued improvement trend for 18-24 months. We see that in a number of our patients with chronic, degenerative diseases. The key is the quality and quantity of the dose as well as the delivery protocol. Re-dosing is the “pharma” model or what we call in the investment business a “recurring revenue” model. We currently have a single dose model and have seen sustained response in a very high percentage of our patients.
We believe more and more literature supports the use of a mixed population of fresh (not cultured) cells. But again, the key is the grade and dose of the cells. When inferior adipose cell processing technology is used it is not just that the amount of nucleated cells can be minimal but they are full of “debris” including the residual collagenase enzyme. The debris, such as red blood cells, and the residual collagenase are inflammatory. It’s a bit like having the idea that fighting with your wife is going to make your marriage better.
Circling back to your first “open ended” question—standards matter. Patients are being confused by doctors as to the number of cells they receive, the sterility of the product and the delivery method. Another confusing practice is when doctors or device makers just add things to their protocols like mixing fat with bone marrow or “laser activation,” which has actually been shown to kill off the stem cells with no support from the literature. There are over 40,000 papers on mesenchymal stem cells, 5,000 on adipose stem cells and plenty on PRP or other biologics that should be used to support the protocols one is using. There is one clinic in Europe I am aware of that combines sheep stem cells with SVF. Since there are no scientific papers that support the safety and efficacy of fetal sheep stem cells, and they have been documented to cause Q-Fever, this seems a little crazy to me—but what do I know?
Q: Do patients have an option of banking their stem cells with you in case they want to return
for additional treatment? Do you use anything but adipose? What are your thoughts on embryonic stem cell treatment?
A: We don’t currently bank as we find the best depot for your biology is your tissue and we, primarily, have a single dose model at this point. We expect to evolve as we gain experience and the science supports change. We do use PRP in combination with ADRCs as the growth factors have been found to enhance the “stem-ness” of the MSCs in the cell preparation.
Embryonic stem cells are just risky. We don’t know what they will grow into since they differentiate into every type of cell in our body. They are developmental cells—not repair cells. We have a framework for explaining the 360˚ repair process that ADRCs provide.
As one of our doctors recently said, not all health conditions are created equal with the same causes or components, but many share common denominators: early inflammation, immune responses, loss of blood supply, premature cell/tissue death and resultant scarring. Stem cells address the most common factors present in chronic, progressive diseases. (Below is an overview of 6 of the key mechanisms of stem cells.)
Had UC treatment April 5th, 2007
Had autologous treatment March 19, 2010
Had bone marrow and adipose stem cell treatment (autologous) June 16, 2010