It was requested that I focus a little more on the science behind our work here at Theravitae. Stem Cell Guy aims to please, so I will go over our clinical trial that we presented in Chicago at the annual American Heart Association meeting in November, 2006.
By using sophisticated tissue culture technology facilitating the isolation, expansion and differentiation of angiogenic cell precursors (ACPs) to an amount sufficient to induce blood vessel formation in the heart, the scientists at TheraVitae have developed VesCell™, which is used now by doctors in Thailand and Singapore for patients suffering from severe heart disease. Cells are isolated from the blood, processed outside the body and then administered to the patient into regions of the heart suffering from reduced blood supply.
Prof. Damras Tresukosol MD Director of Cardiology at the Siriraj Hospital, Mahidol University in Bangkok and the Principal Investigator of the trial, presented the results which showed significant improvement in most patients at six month follow-up:
Over 90% of patients reported subjective improvement of their physical condition and ability to perform physical exercise
Over 70% showed improvement in treadmill exercise capacity
Over 75% of patients showed objective improvement in the perfusion defect of the ischemic region
The results are a major step toward proving the safety and efficacy of VesCell™ therapy, and demonstrate the reliability of TheraVitae’s cell manufacturing process. Moreover, they illustrate the considerable benefits and low risk that VesCell™ therapy provides to patients.
Professor Tresukosol said: “These results are extremely encouraging and reaffirm our belief that VesCell™ can make a substantial and positive difference in the lives of patients suffering from severe angina pectoris.”
Valentin Fulga, MD, CEO of TheraVitae, added: “Working on this landmark study with our Thai colleagues has been both exciting and fruitful. By presenting these encouraging results together at the American Heart Association meeting, we hope to have added our small contribution to the medical community’s knowledge about the utilization of adult stem cell therapies. Together with the recent publication of our scientific article in the British Journal of Hematology., we hope that our technology is starting to become acknowledged by the medical and scientific communities.”
If you would like to read something even drier(albeit interesting to some researchers) than that press release, you can click on that British Journal link above and check out an even more scientific explanation of our work.
Thank you!!!
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I still don’t see an issue with stem cell research. The embryos are going to waste anyway, why not save or improve peoples lives from them?
Stem Cell Guy
Yes, Mr. Bortz,
The stem cells originate in the bone marrow and then circulate in the blood vessels. We always start our process by drawing about 1/2 pint of a patient’s blood from their arm(just like a blood donation). About .1% of that blood is made up of the stem cells. We then isolate those stem cells and multiply them. Later, they are implanted either into the coronary arteries or into the heart muscle itself (depending on the patient’s condition). The best thing about this procedure(s) is the patient’s receive their own stem cells so their body never rejects them.
While the mechanisms of the stem cells are still unknown, many theories abound. The creation of new blood vessels is one. Another theory is the stem cells “wake up” hibernating or weakened heart muscle. Yet another theory, is the stem cells act as sort of a beacon saying “get over here, help us,” and then repair damaged tissue. The stem cells may do all of the above and more. However, there is much research to be done. But no matter the mechanisms, we do know the stem cells are helping our patients. Their symptoms are relieved (angina, shortness of breath, etc.) and most of them have a better quality of life and that is the important thing.
The summary above was of our Phase I trial which is primarily to show that this procedure is safe. There are other companies/universities that have completed similar trials in the US(with similar results). However, to my knowledge, nobody has completed a Phase II or Phase III trial, which is with the double blind/placebo yet which is why the FDA has not approved it in the US. The Thai regulating bodies here saw the results of our trial and gave our company the green light to treat patients on a compassionate basis.
Depending on how fast the cycle of trials are completed, we estimate 5-6 years until this procedure will be accepted in the US.
http://www.thenewsroom.com/details/359315/Health?_id=wom-kg-jlt here is something you can do for your heart, try soy! and check out the video (good for convincing husbands to change to soy milk) – Kate from the womens health desk at thenewsroom.com
angiogenic cell precursors (ACPs) to an amount sufficient to induce blood vessel formation in the heart
If I understood this, you used adult blood-vessel stem cells to improve vascularization of the heart.
I note that the clinical trials were in Asia. Is that because there were legal barriers in the U.S., or just because that’s where the research was being done?
Anyone who has ever had an angioplasty, bypass surgery, or a heart attack can certainly appreciate the potential of this work.
Fred Bortz — Science and technology books for young readers (www.fredbortz.com) and Science book reviews (www.scienceshelf.com)