47 Participants Needed

Gene and Cell Therapy for Heart Attack

(ENACT-AMI Trial)

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ottawa Hospital Research Institute
Prior Safety DataThis treatment has passed at least one previous human 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?

Research indicates that using endothelial progenitor cells (EPCs) for therapy is generally safe, although their effectiveness is still being studied. The safety of these approaches has been observed in various conditions, but more understanding of EPC biology is needed for future trials.12345

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?

DS

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

Your heart's pumping function, measured by echocardiography, must not be too high.
My heart's pumping ability is good after a heart attack.
I had a heart attack in the last 30 days confirmed by an ECG.
See 4 more

Exclusion Criteria

Confirmed pregnant or lactating
I had heart muscle weakness before my major heart attack.
The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Apheresis and Randomization

Participants undergo apheresis and are randomized to treatment groups

1 week
1 visit (in-person)

Treatment

Participants receive the randomized treatment allocation via intracoronary injection

1 day
1 visit (in-person, overnight stay)

Post-Treatment Monitoring

Participants are monitored in hospital overnight for continuous cardiac monitoring

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Clinic visits at 1 week, 1, 3, and 6 months

Long-term Follow-up

Registry to collect long-term safety information from telephone contacts

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous EPCs
  • Autologous EPCs Transfected with human eNOS
  • Plasma-Lyte A and 25% Autologous Plasma
Trial Overview The trial tests enhanced cell therapy for heart attack recovery by using patients' own cells. Some cells are modified with eNOS to improve their function. It's a combination of gene and cell therapy aimed at treating cardiac disease post-heart attack.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Autologous EPCs Transfected with human eNOSExperimental Treatment1 Intervention
Group II: Autologous EPCsExperimental Treatment1 Intervention
Group III: Plasma-Lyte A and 25% autologous plasmaPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Stem Cell Network

Collaborator

Trials
9
Recruited
600+

Citations

Deterioration of cardiac function after acute myocardial infarction is prevented by transplantation of modified endothelial progenitor cells overexpressing endothelial NO synthases. [2019]
Nitric oxide synthase gene transfer restores activity of circulating angiogenic cells from patients with coronary artery disease. [2021]
Overexpression of Nitric Oxide Synthase Restores Circulating Angiogenic Cell Function in Patients With Coronary Artery Disease: Implications for Autologous Cell Therapy for Myocardial Infarction. [2019]
Endothelial progenitor cell-derived small extracellular vesicles for myocardial angiogenesis and revascularization. [2022]
Transplantation of endothelial progenitor cells overexpressing endothelial nitric oxide synthase enhances inhibition of neointimal hyperplasia and restores endothelium-dependent vasodilatation. [2016]
Genetic engineering with endothelial nitric oxide synthase improves functional properties of endothelial progenitor cells from patients with coronary artery disease: an in vitro study. [2014]
Endothelial progenitor cell therapy for the treatment of coronary disease, acute MI, and pulmonary arterial hypertension: current perspectives. [2012]
An optimal non-viral gene transfer method for genetically modifying porcine bone marrow-derived endothelial progenitor cells for experimental therapeutics. [2023]
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