MONTREAL, Canada, December 19 /PRNewswire/ -- The Centre hospitalier de l'Université de Montréal (CHUM) announces the beginning of a phase II randomized double-blind trial with the potential of providing a therapeutic alternative after a first acute myocardial infarction. One patient has already undergone this technique, which consists of implanting immature stem cells from the bone marrow to regenerate heart muscle. The procedure went smoothly and the patient is doing well. This worldwide first, conducted in collaboration with Hôpital Maisonneuve-Rosemont (Montréal, Canada) follows in the footsteps of successful phase I clinical trials carried out in Europe. To date, these preliminary studies have revealed no complications in the subjects treated, after five years of follow-up. These encouraging findings confirm the results of many preliminary experiments carried out on animal models.
- Did you know that cardiovascular disease is the primary cause of death in Western countries?
- Did you know that one hospital bed in five is occupied by someone suffering from heart disease?
- Did you know that myocardial infarction (heart attack), the most frequent cause of heart failure, affects over 250,000 patients in Québec?
"Drug treatment and heart transplant are among the various techniques that can improve heart function. But because the paucity of organs available remains a major problem, CHUM researchers have worked together to set up this innovative research protocol," states Dr. Samer Mansour, cardiologist at the CHUM, and principal investigator for the trial. One of the aims of this trial is to understand the effect of immature stem cells (CD133+), extracted from the patient's bone marrow in the iliac crest, on the healing process of the heart after a first heart attack. The experiment protocol involves intracoronary injection of CD133+ cells against placebo, in addition to standard medical treatment. The entire process takes place during the same period of hospitalization.
"The study of cell therapy in the case of myocardial lesions is relatively recent and we still have a great deal to learn in this trial," adds Dr Guy Leclerc, head of the CHUM's cardiology service. "Previous studies have demonstrated significant improvement of 7 to 10 % in heart function after implanting several types of bone marrow stem cells. In this trial, we will study these immature cells using the most advanced technologies and state-of-the-art imaging techniques to prepare and transplant these cells into the patient."
Bone marrow cells extracted at the CHUM are transferred to the Laboratoire de thérapie cellulaire at Hôpital Maisonneuve-Rosemont (HMR) to isolate the most immature stem cells. According to Dr. Denis-Claude Roy, director of the hospital's research centre, "The fact that the stem cells that have been isolated are immature should improve their capacity to repair the heart muscle."
This clinical trial is one of a body of research projects in regenerative medicine and cell therapy currently being carried out at the CHUM. In these studies, Dr. Mansour and Dr. Nicolas Noiseux, co-investigator for the trial and cardiac surgeon, are attempting to better characterize the mechanisms behind the beneficial effects of stem cells used for the treatment of cardiovascular diseases.
Anticipated impact of the procedure
Currently, this procedure applies to patients who have suffered a first extensive infarction and are at risk for complications such as heart failure. The target population could be broadened once the technique has been further refined and the laboratory protocols perfected. The ultimate goal of this minimally invasive and inexpensive technique, compared to heart transplant, is for it to become more commonly performed in hospitals, in the medium term. The research team includes the following investigators: Drs. Samer Mansour, Denis-Claude Roy, hematologist (HMR), Guy Leclerc, Nicolas Noiseux, cardiac surgeon, and François Reeves, cardiologist (CHUM). Stem cell preparation is carried out at the cell therapy laboratory of HMR under the supervision of Dr Roy. "The contribution of HMR is another good example of complementarity and cooperation in research between the institutions of the RUIS de l'Université de Montréal (UdeM)," states Dr. Denis R. Roy, Director General of the CHUM and president of the UdeM RUIS.
This research protocol was made possible through the collaboration of the Laboratoire de thérapie cellulaire of the Hôpital Maisonneuve-Rosemont, Miltenyi Biotec, the CHUM Research Centre, its radiology and nuclear medicine departments and its cardiology service, notably through its interventional hemodynamics development fund. Health Canada, Fonds de la recherche en santé du Québec, and Boston Scientific also contributed to the trial.
About the CHUM
For documents on the protocol and the intervention, please visit the CHUM website.
For further information: Nathalie Forgue, Communications Advisor, Communications Department, Centre hospitalier de l'Université de Montréal (CHUM), +1-514-890-8000, extension 14342, Pager: +1-514-860-7110; For information on the research procotol: Carole Lemay, or Renée Duclos, research nurses, +1-514-890-8000, ext. 14803; Sources: Samer Mansour, M.D., Cardiologist, Centre hospitalier de l'Université de Montréal (CHUM); Nicole Beaulieu, M.A., ARP, Director of Communications, Centre hospitalier de l'Université de Montréal (CHUM)