Adult Stem Cell Awareness

November 29, 2007

TheraVitae: Adult stem cell therapies remain vitally important

Filed under: adult stem cell awareness — benotafraid @ 7:05 pm
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Is there anything more American than finding a way to get things done? This is just the image I have of Don Margolis, founder of TheraVitae, an international adult stem cell company: gentleman rebel, impatient bio-entrepreneur, and pragmatist with a heart. Margolis endured the loss of his wife to cancer and found himself a man with a new a mission in life – to restore hope to those that conventional medicine seemed content to leave behind.

Margolis raised both enough cash (largely from venture capitalists), and interest among some professionals in regenerative medicine, but he found the FDA was just not on board –  needlessly, he thought, playing name games with stem cells to slow down the process of approval.  It would take years and many more millions to do all Margolis hoped to do – unless, that is, he based his company elsewhere. And so, several clinical trials and 275 patients later, TheraVitae works from VesCell clinics within hospitals primarily in Bankok and Singapore  

Therapies unapproved by the FDA, venture capitalism, exotic cities, last hope for dying patients, foreign doctors, medical tourism . . . the unfounded impression of intrigue and impropriety is one that TheraVitae has dealt with  from the beginning.  For reasons perhaps better left unexplored, we Americans have a difficult time combining certain concepts. Is there something wrong with making money from cutting-edge life-saving therapies? Surely not, given the strength of the pharmaceutical industry in our country. Are Thai medical standards and medical ethics inferior to our own? There is no reason to assume as much. “Foreign” doctors have been saving lives within the U.S. for years.

Margolis and, as far as I can tell, his professional team are neither here nor there with regard to the ethics of using human embryos in research and clinical treatments. Ever-pragmatic, he simply sees through the consistently empty promises of “potential” cures promulgated by the media on behalf of embryonic stem cell labs in the U.S. and abroad. Autologous stem cells, in this case, blood cells have worked already –  improving heart function and extending lives. Trials with autologous blood cells for cardiac patients have recently been ongoing in the U.S., but as with all trials – those in most desperate need are often exluded. Some among this category of patients are sometimes (if not often) accepted for treatment by TheraVitae clinics, if their own cardiologists will consent.

Because of VesCell treatments, Hawaiian performer Don Ho was able to spend an extra year and a half doing what he loved to do, sing on stage. Like Ho, most who pursue VesCell treatments are older and in end-stage heart failure. Many were, before treatment, hospice bound. But not all are “old”. The parents of a young disabled woman from Pennsylvania hope VesCell treatments will curtail the need for a heart-lung transplant – all she’s eligible for here in the U.S. I thought we’d send a few questions over to  “StemCellGuy“, TheraVitae’s apparent online spokesperson. He quickly and graciously replied – so let’s get to it:

 ASCA: Is VesCell available yet in the U.S.? If not, why not?

StemCellGuy: No, VesCell is not available in the U.S. as our goal has always been to help as many patients as possible as soon as possible. Waiting 5-10 years (to run through the clinical trials for) for the FDA to approve our stem cell therapy didn’t seem the best way to attain that goal. However, we haven’t closed the door on the possibility of treating patients in the U.S. In fact, we are now in talks with some hospitals and doctors to begin a Phase II trial in the U.S.

ASCA: Okay, so that’s why you are still based outside the U.S – does the fact that you are based overseas create any kind of P.R. problems/anxieties with regard to patients and their physicians here in the U.S.? Do they initially worry that you are just some kind of opportunistic bio-tech without any real medical merit?

StemCellGuy: This again relates to our goal of wanting to help patients now. Approximately 700, 000 die in the United States each year from heart disease. By the time adult stem cell therapy for heart disease is approved, more than 3 million Americans will have died, perhaps unnecessarily because it isn’t approved yet in the U.S. Now, to your second quesiton, yes, it is a big issue. Many cardiologists and heart patients take the “if it isn’t approved yet here in the U.S., it doesn’t work or exist” point of view. However, the word is getting out. We are slowly changing the perception that we are a “scam”.

Almost every single one of our patients will tell you that the standard of care they receive here from our hospital and our doctors is on par or better than any in the United States. Most of the doctors we work with are accredited to practice in the U.S. as well. Furthermore, TheraVitae offers to pay the way for any cardiologist to accompany his/her patient to Asia to observe our stem cell therapy and see that their patient is well taken care of. We have convinced many “doubting Thomas'” and skeptics that way.

ASCA:  Has TheraVitae been able to  make in any inroads with regard to treating pediatric patients yet?

StemCellGuy: No. Unfortunately, when a new therapy/treatment/drug comes along, the children are usually the last to benefit. And so it is the case with us. To date, we have not treated any children. However, in theory, adult stem cells should be beneficial to kids as well. With adult stem cells, in every patient (child or adult), be it heart, diabetes, stroke . . . the best case scenario is that it helps heal/cure, and in the worst case scenario, the stem cells do nothing (no side effects because it is the patient’s own cells). You have to like those odds.  

ASCA: Oh, I do! Now, will those newly acclaimed iPSC’s have any bearing on TheraVitae’s research or clinical applications? Will iPSC’s make any difference to heart patients? It seems to me adult stem cells have always performed better for hearts, but I may be mistaken.

StemCellGuy: None. While these new iPSC’s may have solved some ethical/moral issues, it didn’t solve the problems of tumors, rejection, mutations, etc – which will take decades to solve. I am sorry to sound like a skipping CD or broken record, but we want to help patients now and there is no better way to do that than using their own cells to help heal them.

ASCA: Our audience is largely Catholic and we want to see the end embryonic stem cell research. What does TheraVitae have to say to us?

StemCellGuy: What TheraVitae is accomplishing with our heart patients is just the tip of the iceberg. We can still (and will) improve our technology and other researchers around the world will develop new treatments/technology using adult stem cells. The “promise” and “potential” (two words you will see in any embryonic stem cell article) of adult stem cells are in the eyes of our treated heart patients, not just empty words in the New York Times. We want to make the benefits of adult stem cell therapy more widely known and available to everyone. Not only is it both safe and effective, it is also one of America’s best kept secrets. Please help me get the word out.

 ASCA: What’s TheraVitae looking at tackling next?

StemCellGuy: Perhaps that clinical trial for heart patients that I mentioned earlier, either in the U.S. or Canada. We also want to concentrate more on our new peripheral artery disease (PAD) treatment.

ASCA: Okay sounds great — thanks StemCellGuy!

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4 Comments »

  1. Great posting and great feedback from Stem Cell Guy! I’m a big Stem Cell Guy fan (I’m an aspiring medical researcher, currently in college, and I try to keep up on adult stem cell research/therapies)so I was happy to see that he shared his expertise here. I think TheraVitae has the right attitude/perspective and the tools to make a big impact (they have clearly already started to)…I hope the FDA takes note. Thank you and thanks to Stem Cell Guy!

    Comment by Mandy Rudy — December 19, 2007 @ 4:36 pm | Reply

  2. Yeah, we need them here in the U.S.! I didn’t get any stats on how many patients thus far are Americans, but I think we can be confident it’s the vast majority.

    Comment by benotafraid — December 19, 2007 @ 5:33 pm | Reply

  3. UPDATE:
    I retired from TheraVitae last summer shortly after my 73rd birthday. My twelve hour days have turned into 15 hour days in my new mission, which is to bring Autologous Stem Cells much closer to America, starting with Diabetes treatments.

    Yes, as the above writer surmised, about 2/3 of those 275 treatments were for Americans.

    You wrote; “Are Thai medical standards and medical ethics inferior to our own? There is no reason to assume as much. “Foreign” doctors have been saving lives within the U.S. for years.”

    In the fall of 2004, we were about halfway through our phase 1 clinical trial. So we went to the Thai cardiologists and suggested we start planning for Phase 2 because we wanted to start ASAP after Phase 1. They told us “There will be no Phase 2!”
    “Whaaat?”
    “You have proven safety, and efficacy seems on track. You will start treating really sick people on January 1, not those lucky enough to qualify for a trial!”

    Compare that to the Land of the Free, where despite absolute proof in 2003, 200,000 chronically ill heart failure, angina, and cardiomyopathy patients are dying each year who could be saved by long-proven, super-safe Autologous Stem Cells.

    But the really sad news is that 5.5 MILLION Americans have been diagnosed with Congestive Heart Failure and are suffering from reduced energy, shortness of breath, and chest pains. TheraVitae, perhaps the tiniest stem cell company ever, developed its technology in no-time, and improved the quality of life of 75% of those treated—and 1/3 of our American patients are willing to give up their right to medical privacy to tell YOU about it!

    By the end of 2007, TheraVitae has helped 200 more heart patients that EVERY EMBRYONIC RESEARCHER IN THE WORLD will help in the next ten years. See you in 2018.

    Don Margolis
    Autologous Stem Cell Advocate

    The word for stem cells taken from the patient’s own body, and
    then reimplanted into that body to do the most good, is AUTOLOGOUS,

    I believe these specific cells will be proven over time to be the
    most beneficial type of stem cell for the sick patient.

    THAT is why God made stem cells in the first place, to help keep THAT ONE PERSON alive and healthy!
    —DM, March 2008

    Comment by Don Margolis — March 23, 2008 @ 9:37 am | Reply

  4. Terminology is so important isn’t it? You are probably on to something – it’s a great way to get the word out without pressing any buttons, using “autologous” vs “adult”.

    I thought I recently read somewhere that VesCell would be used in the U.S. … soon. What perplexes me is that we do have some centers, like the Texas Heart Institute . . . are they using essentially “VesCell” under a different patent (or whatever)? What makes their therapy sanctionable in the U.S., but not TheraVitae’s?

    Comment by benotafraid — March 23, 2008 @ 4:31 pm | Reply


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