Gene and Cell Therapy for Heart Attack
(ENACT-AMI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This will be the first clinical trial to include a strategy designed to enhance the function of autologous progenitor cells by overexpressing eNOS, and the first to use combination gene and cell therapy for the treatment of cardiac disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is the gene and cell therapy for heart attack generally safe in humans?
How does the treatment using Autologous EPCs and eNOS-transfected EPCs for heart attack differ from other treatments?
This treatment is unique because it uses the patient's own endothelial progenitor cells (EPCs) that are genetically modified to overexpress endothelial nitric oxide synthase (eNOS), which helps repair blood vessels and improve heart function after a heart attack. Unlike standard treatments, this approach aims to enhance the body's natural repair mechanisms by boosting the regenerative capacity of the cells.23567
What data supports the effectiveness of the treatment Autologous EPCs, Autologous EPCs Transfected with human eNOS, Plasma-Lyte A and 25% Autologous Plasma for heart attack?
Research shows that endothelial progenitor cells (EPCs) can help repair heart tissue after a heart attack by promoting new blood vessel growth. When these cells are modified to produce more nitric oxide (a molecule that helps blood vessels relax and improve blood flow), they are even more effective in repairing heart damage and improving heart function.13578
Who Is on the Research Team?
Duncan Stewart, MD, FRCP C
Principal Investigator
Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who've had a successful stent implantation after a heart attack within the last month, are stable, and have reduced heart function (LVEF ≤45%). Women must meet specific reproductive criteria. Exclusions include autoimmune disease treatment, significant heart issues unrelated to the recent attack, HIV or hepatitis B/C infection, non-compliance history, other investigational treatments currently or in the past.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and Randomization
Participants undergo apheresis and are randomized to treatment groups
Treatment
Participants receive the randomized treatment allocation via intracoronary injection
Post-Treatment Monitoring
Participants are monitored in hospital overnight for continuous cardiac monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Registry to collect long-term safety information from telephone contacts
What Are the Treatments Tested in This Trial?
Interventions
- Autologous EPCs
- Autologous EPCs Transfected with human eNOS
- Plasma-Lyte A and 25% Autologous Plasma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Stem Cell Network
Collaborator