This experimental therapy uses the patient’s own stem cells extracted from their blood soon after a major heart attack. These cells are enhanced in the laboratory with the insertion of a gene called endothelial nitric oxide synthase, which stimulates blood vessel growth and improves tissue healing. These enhanced cells are then infused back into the patient’s heart.
The first patient was treated at the University of Ottawa Heart Institute, whose CEO, Dr. Duncan Stewart, is the lead principal investigator of the trial. Dr. Stewart developed the research project with Dr. Michael Kutryk, a cardiologist at St. Michael’s.
“Over the last decade, a number of studies have been reported that used a patient’s own stem cells to treat patients after they have suffered a heart attack. Although the results of these trials have been promising, the improvement in heart function has been modest,” said Dr. Kutryk. “By enhancing the capacity of these cells to repair the damaged heart, we hope to see a significant improvement in a patient’s heart function after treatment. This is the first time that a cell enhancement strategy will be tested in a clinical trial for cardiovascular disease, and if successful will change the way that we treat patients who have suffered a major heart attack.”
“Stem cells have incredible potential to repair and regenerate damaged organs, but cells that come from heart attack patients don’t have the same healing abilities as those from young, healthy adults,” said Dr. Stewart. “Our strategy is to rejuvenate these stem cells by providing extra copies of a gene that is essential for their regenerative activity, so that they better stimulate heart repair and restore the heart’s ability to pump blood efficiently. In other words, to help the heart fix itself.”
The formal name of the clinical trial is ENACT-AMI, which stands for Enhanced Angiogenic Cell Therapy – Acute Myocardial Infarction. The randomized trial will involve 100 patients recruited over two years from St. Michael’s and UOHI. One-third of the participants will receive genetically enhanced stem cells, a third non-enhanced stem cells and a third a placebo.
St. Michael’s expects to enroll its first patients this fall. The trial hopes to later recruit patients from Sunnybrook Hospital (Toronto), the Jewish General Hospital (Montreal) and l’Institut de Cardiologie de Montréal.
The trial has been supported by a $2 million gift from the Krembil Foundation, some of which went toward expanding the Krembil Laboratory at St. Michael’s where the genes are inserted into the patient’s stem cells. Harriet Garrow, the trial’s first participant, suffered a heart attack on July 2 at her home in Cornwall, Ont., and her heart stopped beating completely. Emergency medical personnel resuscitated her took her to a hospital in Cornwall, from where she was transferred to the UOHI. Despite receiving all available modern heart attack therapy, including opening her blocked artery with a balloon catheter, she suffered extensive damage to her heart and was enrolled into the ENACT-AMI trial.
“I am learning that my life will change fairly significantly because of my heart attack,” said Garrow, who does not know which of the three treatment options she received. “So I am thrilled to play a part in this research that could help people like me in the future and, who knows, perhaps even my children and grandchildren—although I hope they won’t need it, of course.”
The ENACT-AMI trial is also funded by the Canadian Institutes of Health Research and The Ottawa Hospital Foundation. Additional support for research development and infrastructure has been provided by the Stem Cell Network, the Canada Foundation for Innovation and the Ontario Research Fund. Abbott Vascular Canada donated the catheters used for stem cell delivery into the heart.
About St. Michael’s Hospital
St Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in 27 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the Hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael’s Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.
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