Good Morning Everyone! Stem Cell Guy would like to present Don Margolis. Don is the founder of my company Theravitae and would like to say a few words to all you internet people out there. This essay is a little lengthy, but I think you will find it interesting, especially if you or someone you know has heart disease. Yes, there is a little self promotion going on, but it is also to let you know that there are other companies/places helping heart patients now.
To Heart Patients Everywhere:
In 2004-05 TheraVitae’s scientists developed and patented a new process and started treating heart patients with stem cells. We do not use the controversial embryonic cells, or even umbilical cord stem cells. We draw a small amount of blood from each patient and extract a small amount of adult stem cells from that blood. We put those cells through a natural process that makes them more powerful and far more numerous than they were to start with. Then we inject those stem cells into the cardio-vascular systems of our patients.
We have gathered momentum over the past 18 months as our scientists and world-class cardiologists have increased their knowledge. As of now, Nov 1, we have treated over 275 heart patients, and the results, which you will see in detail, have been more than good.
But we at TheraVitae are far from the only ones now putting new life into the veins of heart patients. There are today, all over America, about two dozen heart institutions conducting or starting clinical trials using adult stem cells to help heart patients, and, mostly, they are having results as good as ours, perhaps some even better. The first was Texas Heart Institute in Houston in 2004, later Scripps in southern California, St. Elizabeth’s in Boston, Columbia University in New York, University of Pittsburgh, Minneapolis Heart Institute, Johns Hopkins—the list goes on and on. Then there are bio-companies doing advanced work on adult stem cells for heart patients. And for every researcher in America, there perhaps ten others around the world working on how to deliver stem cells to heart patients.
Some use the patient’s bone marrow to harvest adult stem cells. Some use different kinds of adult stem cells. Others, like us, use the patient’s blood to produce adult stem cells. It all seems to work well, with varying degrees of success…. but that just helps to prove our point that adult stem cells, taken from the patient, can relieve the suffering of the very-ill heart patient NOW.
We at TheraVitae have brought a new life to about 200 people from many different countries. Our work has been publicized all over the world. Time Magazine carried two stories about our work. A Reuter’s story circulated in print, on TV and on the internet. Several USA newspapers and TV stations have interviewed our patients.
Our work has been in Business Week, Newsweek, and all over the internet (literally) during the past twelve months. We presented a paper with early results of our 24-patient clinical trial at the American Heart Association science meeting in Dallas November 2005 and they invited us to submit the final results again November 2006. The World Economic Forum named TheraVitae as a “Tech Pioneer” and invited us to Davos, Switzerland in January to rub shoulders with the very top level of business executives in the world. Finally, Frost & Sullivan, the world’s leading analysts, named us their biotech champs of 2007.
Why all this recognition for such a tiny company? It’s not that complicated:
1—Our Israeli scientists and our cardiologists in both Israel and Thailand have, over the past two years, developed the science of the cells and solved most of the mysteries of safely placing them into our patients’ cardio-vascular systems.
They did this by first working in the laboratory and then by actually helping patients.
In other words, they didn’t talk much about it, they just got the job done and started helping people.
2—We use stem cells taken from the patient’s own blood. These cells have many advantages besides merely avoiding political and religious controversy:
(a) Our cells will not be rejected by the patient’s immune system…they are his own, perfectly matching his DNA. Therefore no drugs need be used to suppress the immune system and open the door to later cancers.
(b) They can be implanted using procedures which are as safe as, or safer, than some other cardiac procedures.
(c) They produce more than just “acceptable” results, much more.
Since most of the scientific obstacles have been overcome, all that remains is to treat people and to learn which procedures are safest and exactly which cells produce the most benefits. That can best be done without condemning today’s patients to a short life, filled with suffering; but rather by treating thousands of people and collecting a mountain of data now.
Years ago, when bypass surgery was developed, no one suggested years and years of clinical trials. They plunged ahead, made mistakes, corrected them, always improving the science and perfecting the procedures until they reached today, with much better science, safer procedures, and still imperfect! How many lives would have been condemned to pain and ultimately lost if they had waited until today’s safer, more effective procedure had been held back?
Now to the main point of this essay. TheraVitae developed two ways to use those stem cells we go to so much trouble to produce. The first was to use a catheter to implant the cells into the coronary arteries. It was thought that these cells, given a chance to attach to the wall of a fully-blocked or partially-blocked artery would find a way to deliver more blood to the heart. Some thought that stem cells would make their way to the heart muscle and make it stronger. But we decided that for now it doesn’t matter how the cells work. The only thing that matters to TheraVitae is to save and improve lives, as many as possible, NOW.
Later, thanks to a brilliant USA doctor, Amit Patel, we started using a second procedure in some cases, but for now we will concentrate on that catheter therapy. It is very close to the commonly used “balloon angioplasty,” a procedure which, using a special catheter with a balloon, expands the blocked artery and allow more blood to get to the heart. Our procedure is similar to the angioplasty, but we put the stem cells in, block them so they don’t wash away, thus allowing them to attach to the walls of the artery so that they soon start their “magic.” Magic because no one really knows, even at this date, exactly how stem cells improve the patient’s condition, but everyone in over 25 countries who is into adult stem cell research knows they work.
We have conducted a 24-patient clinical trial in Thailand using this procedure. Since a year of follow-up is necessary, the patients had to meet the medical criteria and live in Thailand to qualify. We now have results we can show you (please pardon the technical language from our research doctors):
The results of this trial showed very significant improvement in the patients’ clinical condition. Cardiologists measure the severity of the symptoms by a scale called the Canadian Cardiovascular Society scale (CCS) which represents the degree of incapacitation of the patient and the extent by which angina pectoris interferes with everyday life. In the clinical trial almost 90% of the patients improved. The average CCS score was almost halved, from 2.1 before treatment to 1.18 six months later, indicating a remarkable reduction in the severity of the patients’ symptoms and extent of incapacitation.
Objective tests, not depending on descriptions by the patients, also improved. A test which measures the distance which a patient can walk in six minutes improved in 90% of the patients in three months and in all of them after six months. Most patients improved also at a treadmill exercise test. The improvement in this test was by an average of 26%.
The defect in blood supply to the heart (which causes the symptoms and incapacitation of angina pectoris) is the direct pathology VesCell is addressing which can be measured objectively. The average measured deficiency in blood supply to the heart was almost halved, from 37% before VesCell to 24% at 3 months and to 21% at 6 months. Again, this improvement occurred in the majority of patients. The side effects were not significant and none could be attributed directly to the cells themselves.
Note: We have available, for you or your cardiologist, a more detailed scientific report should you need one, plus, of course, the paper we submitted to the AHA in Dallas last year.
Finally, we decided to do something no one else dares do—no one! We chose a group of the first forty patients treated with this therapy outside the clinical trial and have interviewed them continuously since last December. We knew that stem cells do not cure heart disease; they merely improve the quality of life and move the patients further away from death’s door. But angina and heart failure are still there. So we wanted to stay on top of problems and help those who had them. We tried to interview each and every one, twice a month, and kept records of those interviews. Now you can peek over our shoulder and see what our treated patients have to say.
Of course, to respect privacy, we identify them only by age, and gender. We show you the clinical complaints each individual had prior to our therapy. We show you all the medical facts of the forty as a whole…like 100% had moderate to severe ischemia, 87% had heart failure, and….well, here’s what the 40 looked like, medically speaking:
# patients
Valve (Mild to Moderate problems) 23 57.5%
Angioplasty (1 to 6 previously) 28 70.0%
CABG (1 to 3 bypasses previously) 28 70.0%
Pacemakers and/or defibrillators 18 45.0%
Acute MI (1 to 5 previous heart attacks ) 24 60.0%
Congestive Heart Failure 35 87.5%
Angina 31 77.5%
Hypertension 30 75.0%
Dislipidemia 37 92.5%
Diabetes Mellitus 21 52.5%
Gout 6 15.0%
You can now see that we did not choose slightly ill patients to look good in this report. The patients chose us. They chose us because they were very, very sick and not getting any better. Now most of them, over 75%, are better.
We have an arbitrary letter assigned by our doctors to each treated patient’s record:
A for excellent recovery
B for improvement
C for no improvement
X for unable to interview. (Remember, this is not a clinical trial and no one is obligated to be tested or to submit to an interview.)
A scientist would say these results are “anecdotal.” We agree. Each one is anecdotal, taken on its own. But 30 different stories, backed up in some cases by cardio tests, start to mean more than an anecdote. So many could barely get up from the sofa before and now they are physically active. Placebo effect? Who knows? But what would you prefer, living the rest of your life on the sofa, not even able to climb a flight of stairs, or enjoying the greatest “placebo effect” ever seen? We leave that for you to decide.
The report shows that 80% of those treated and interviewed say that their lives have noticeably improved. You don’t have to take our word for it. Over two dozen of these clinical successes who speak English have agreed to talk to new patients who want to talk to them. We call them “Patient Volunteers,” people who are so happy to feel so much better, they want to talk to other people who are now where they were last year. That way they feel that they are “giving something back.”
They may say that “I’m a new man,” or “I am somewhat better,” or even “I don’t feel any better at all.” Indeed, their cardio problems don’t stop; they are merely reduced in most cases. They still need their prescriptions adjusted as conditions change. They still have to watch out for fluid retention. They still have to watch their diets, not smoke, and exercise moderately and regularly.
Indeed, some people will die — not from the therapy; but because they fell into that 20% category, or that they were too sick for the cells to help them in time. But by and large, the overwhelming majority are living more active lives, mostly (or entirely) free from chest pains and breathing problems. So see their stories at http://www.vescell.com and you will find yourself in many of them.
When you are finished, decide for yourself whether “the science is still unproven” as some with a huge ax to grind say. Of course, if you are still a bit skeptical, feel free to speak to our Patient Volunteers. They want to talk with you.
Don Margolis
Founder, TheraVitae
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