An International First at the CHUM - Promising Treatment in Regeneration of the Myocardium Through the use of Stem Cells

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.

Some facts

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

http://www.chumontreal.qc.ca.

For documents on the protocol and the intervention, please visit
the CHUM website.

Contact:

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)

An International First at the CHUM - Promising Treatment in Regeneration of the Myocardium Through the use of Stem Cells

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