My buddy David S. is raising funds for stem cell treatment for his heart. He is a gentleman, a poet, a musician and he always seems to get right to the meat of the subject. David asks:
What was the method used to develop [adult stem cell] therapies all over the world in other countries? Clinical trials?
Short answer: American medical professionals are so Ameri-centric, they throw away or ignore anything (studies, trials, etc) conducted outside the USA.
I remember a few years ago, an acquaintance of mine who was pre-med sneered at my mention of any trials conducted outside the US and then sneered at the very thought of adult stem cells doing anything. Well, I guess I’m laughing last but I brought up the point then that his arrogance was somewhat confusing to me since the USA health system is ranked 37th in the world by the World Health Organization. What the hell was he so proud of??
HERE’S WHAT HAPPENED…
in 2005 the first stem cell treatment facility was created in Thailand where the environment was favorable (the king’s cardio thoracic surgeon was a fan of stem cells for heart disease) and theIr methods were based on half a decade of human research preceded by years and years of animal research. I present a short list of the ‘ignored’ studies below. Read through and you will realize:
a. by the time these studies were published, everyone in the scientifically community new the results for a year or years and
b. by the time the Bangkok facility was created, Prof Doris Taylor was already creating hearts with stem cells from scratch
c. these studies and trials, when conducted outside the US, have been all but ignored and then repeated in the US. The inevitable successful trial results 6-8 years later in the US are always accompanied by an incorrect, ignorant and infuriating news article crying: “first ever in the world!”
d. in addition to the studies/trials below, there were also hundreds or thousands of other studies showing the safety and efficacy of adult stem cell treatments in animals and humans in other organs/parts of the body.
[While, 'it worked there, so it will work here' is not an accepted scientific method, at some point there is an increase in confidence when you realize: adult stem cells are in the body to repair, that's what they do, they are safe, they fix stuff, now let's figure out how to maximize there effects.]
For more information: http://repairstemcell.wordpress.com/heart-disease-treatment/
HEART DISEASE CLINICAL STUDIES – A BRIEF HISTORY
A clinical trial led by Dr. Hans Dohmann plus six colleagues in Brazil took 21 transplant candidates and gave 14 of them bone marrow cells. The results were so spectacular that the American Heart Association accepted the paper and it was presented in 2003. Five of the seven in the control group opted in to make a total of 19 stem cell transplants. The mortality rate for transplant candidates is about 35% per year. At that rate there would be, of those 19, only 2.2 patients still alive without a transplant after five years. There were, in fact, 12 alive as of Dec. 31, 2007; more than five years down the road.
If you did not want or could not get a heart transplant (as is true of 90%+ of dying heart patients in North America) then you had to make a choice between stem cell treatment or standard Western Cardiology methodology.
Western Cardiology methodology kept 12% of patients (waiting for heart transplants) alive for five years.
Adult/repair Stem cell treatments kept 63% of patients (waiting for heart transplants) alive for five years. More than 5 times more heart transplant candidates lived for 5 years with stem cell treatments than the typical heart transplant recipient! Btw, stem cell science has made huge advancements in treating heart disease over the past seven years.
Dr. Andreas Zeiher of the Goethe Institute in Frankfurt began much larger trials. As of 2007, he has overseen more ASC implants into hearts than anyone, both in and out of clinical trials and he was the first to prove that timely implant of RSC in new heart attack victims improves future mortality and morbidity – http://circ.ahajournals.org/cgi/search?journalcode=circulationaha&fulltext=zeiher
Dr. Amit Patel of Pittsburgh completed two of the most successful trials ever. In Uruguay, he proved, on a group of ischemic heart failure patients, that a bypass plus cells was infinitely better than a bypass only. That same year, TheraVitae, in Israel, developed a new, powerful blood-derived stem cell and dared to treat the sickest patients no clinical trial (except Brazil) would consider.
One of the Brazilians, Dr. Perin, came to Texas, used the Brazil results to get the first ASC heart clinical trial approved by the FDA. Over a dozen such approvals were granted in the next 12-18 months.
The first-ever commercial stem cell treatment center in the world starts adult stem cell treatment of hundreds of human patients. Results are amazing and include the regrowing of cardiac muscle tissue in patients, significant increases and sometimes a doubling of ejection fractions (the % volume of blood the heart can pump out per beat), etc! Stem cells are also recognized as “smart,” going to where they were needed most, creating micro-vessel bypasses around existing blockages areas, areas that previously were blocked and in areas where stents were implanted.
Dr Taylor removed all cells from rat hearts except for a thin skeleton of tissue translucent as wax paper. She then injected the scaffold with fresh Cardiac Repair Stem Cells from newborn rats. Four days later, “We could see these little areas that were beginning to beat. By eight days, we could see the whole heart beating.” The experiment, reported in the journal Nature Medicine, marked the first time scientists created a functioning heart in the lab from biological tissue.
ADULT STEM CELLS vs. HEART DISEASE – UNDENIABLE SCIENTIFIC EVIDENCE
HEART DISEASE TRIAL – 2004 to 2006 –
Clinical trial illustrates the safety and efficacy of VesCell Adult Stem Cell treatment. Accepted by the American Heart Assn in 2005-6. This trial was a key element in attaining regulatory approval for the treatment protocol that improved the lives of 300 mostly “no-option” heart patients.
BRITISH JOURNAL OF HAEMOTOLOGY – 2006
Research paper shows that peripheral blood derived stem cells can differentiate into a variety of other stem cells (angiogenic, myocardial and neural lineages) and do so in sufficient quantities to use as autologous treatment for a variety of diseases.
ANGIOGENIC CELL CLINICAL STUDY – 106 CASES – 2005 to 2008
Clinical study at Chao Phya Hospital Heart Center and Siriraj Hospital H.M. Cardiac Center clinical study shows that transcoronary injection of angiogenic cells precursors improved cardiac/left ventricular ejection fraction (LVEF), exercise capacity and quality of life with high safety profile for 70% of ischemic cardiomyopathy patients with no-option revascularization.
CARDIOMYOPATHY TRIAL – 55 CASES – 2005 to 2006
Bangkok Heart Hospital and U of Pittsburgh Medical Center/McGowan Institute for Regenerative Medicine clinical trial shows that expanded autologous blood derived stem cells utilized in intramyocardial transplantation is feasible and safe in severely ill patients with intractable heart failure in all cases of dilated cardiomyopathy (DCM) and in both first-time and “redo” ischemic cardiomyopathy (ICM) patients.
PERIPHERAL ARTERY DISEASE – SCIENTIFIC PAPER – 6 CASES
Shows the safety, and feasibility and enhancement of limb salvage from implantation of non-mobilized peripheral blood angiogenic cell precursors (NMPB-ACPs) in 80% of patients with critical limb ischemia (CLI) who were poor candidates for standard revascularization treatment options.
BIOPROCESSING JOURNAL – 2007
Bioprocessing Journal scientific paper shows the consistent and reliable manufacturing procedure utilized for transforming bone marrow and blood-derived stem cells into angiogenic cell precursors (ACPs) and hematopoietic stem cell (HSC) cellular products for the treatment of severe heart diseases. End product was found to be a) safe and effective; b) prepared from non-mobilized peripheral blood; c) stable, with a relatively long shelf-life; and d) ready-to-use and easily utilized by the physician.