First patient treated in groundbreaking stem cell therapy trial for heart attack
September 5, 2013
Ottawa, Canada — Canadian researchers have treated the first patient in a world-first clinical trial using genetically enhanced stem cells to repair damaged heart muscle after a major heart attack. The formal name of the trial is ENACT-AMI, which stands for “Enhanced Angiogenic Cell Therapy – Acute Myocardial Infarction.”
“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. Duncan Stewart, who is the Lead Principal Investigator of the trial, CEO and Scientific Director of the Ottawa Hospital Research Institute (OHRI), Vice-President of Research at The Ottawa Hospital and Professor of Medicine at the University of Ottawa.
“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, reduce scar tissue and restore the heart’s ability to pump blood efficiently — in other words to help the heart fix itself,” he said today at OHRI's Sprott Centre for Stem Cell Research.
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 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 heart of the same patient.
The ENACT-AMI trial is coordinated by OHRI and will enroll 100 patients over two years, with initial recruitment beginning at the University of Ottawa Heart Institute and St. Michael’s Hospital (Toronto). ENACT-AMI is a randomized, double-blinded controlled trial. A third of the participants will receive genetically enhanced stem cells, a third non-enhanced stem cells and a third a placebo.
"This project illustrates how researchers and clinicians in Ottawa, and across Canada, are committed to working together to translate exciting basic research into innovative therapies that could have far-reaching benefits for heart patients here and worldwide," said Dr. Peter Liu, Scientific Director of the University of Ottawa Heart Institute.
Dr. Michael Kutryk, the trial's principal investigator (PI) at St. Michael's Hospital, added: “Researchers at St. Michael’s Hospital have played a key role in the early development and testing of this new therapy from the very beginning, and we’re delighted that this groundbreaking clinical trial is now under way.”
Subsequently, additional sites will start recruiting participants, including Sunnybrook Hospital (Toronto), the Jewish General Hospital (Montreal) and l'Institut de cardiologie de Montréal.
Harriet Garrow is the trial's first participant. She suffered a heart attack on July 2, 2013, at her home in Cornwall. Her heart stopped beating completely. She was resuscitated by emergency medical personnel and taken to a hospital in Cornwall, before being transferred to the University of Ottawa Heart Institute. Despite receiving all available modern heart attack therapy, including opening up her blocked artery with a balloon catheter, she suffered extensive damage to her heart and agreed to be enrolled into the ENACT-AMI trial by Heart Institute PI, Dr. Chris Glover.
"I am learning that my life will change fairly significantly because of my heart attack," said Harriet 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 funded by the Canadian Institutes of Health Research, The Ottawa Hospital Foundation and the St. Michael's Foundation (through support from the Krembil Foundation and the Hummel bequest). 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. The special catheters used for stem cell delivery into the heart have been donated by Abbott Vascular Canada. We would also like to recognize the important contributions Canadian Blood Services has provided to support the trial.
"I’m proud that scientists in Ottawa are leading this world-class research," said Dr. Jack Kitts, CEO of The Ottawa Hospital. "This is an excellent collaboration that shows how important research-based hospitals are to the innovation that improves health care."
“CIHR is pleased to support this ground breaking study which shows Canadian leadership in the field of stem cell research,” said Dr. Alain Beaudet, President of the Canadian Institutes of Health Research. “This study aligns with CIHR priorities in bringing new innovative treatments to patients in Canada and producing meaningful solutions to major health challenges in this country.”
ENACT-AMI follows Health Canada regulations and has been approved by the Ottawa Health Science Network Research Ethics Board. Eligible participants must have suffered a heart attack within the last 30 days, and must have been treated at one of the participating hospitals. Other eligibility criteria and details for health professionals are available here: clinicaltrials.gov/ct2/show/NCT00936819.
Video clips from Dr. Duncan Stewart
≫ What is the ENACT-AMI clinical trial? (0:42)
≫ What happens to the heart in a heart attack? (0:26)
≫ What is the problem this trial addresses and what strategy is being used to overcome this? (1:17)
≫ Why is ENACT-AMI significant? (1:09)
≫ Full video
Manager, Communications and Public Relations
Ottawa Hospital Research Institute
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Senior Manager, Public Affairs
University of Ottawa Heart Institute
Manager, Media Strategy
Communications and Public Affairs Department
St. Michael’s Hospital
About the Ottawa Hospital Research Institute (OHRI)
The Ottawa Hospital Research Institute (OHRI) is the research arm of The Ottawa Hospital and is an affiliated institute of the University of Ottawa, closely associated with the university’s Faculties of Medicine and Health Sciences. OHRI includes more than 1,700 scientists, clinical investigators, graduate students, postdoctoral fellows and staff conducting research to improve the understanding, prevention, diagnosis and treatment of human disease. Research at OHRI is supported by The Ottawa Hospital Foundation. www.ohri.ca
Ottawa Hospital Research Institute Fact Sheet
About the University of Ottawa Heart Institute
The University of Ottawa Heart Institute is Canada’s largest and foremost cardiovascular health centre dedicated to understanding, treating and preventing heart disease. UOHI delivers high-tech care with a personal touch, shapes the way cardiovascular medicine is practiced and revolutionizes cardiac treatment and understanding. It builds knowledge through research and translates discoveries into advanced care.