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Cell Therapy

Gene and Cell Therapy for Heart Attack (ENACT-AMI Trial)

Phase 2
Waitlist Available
Led By Duncan Stewart, MD, FRCP C
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of anterior ST-elevation myocardial infarction within the last 30 days, with specific 12-lead electrocardiographic changes
In the case of a previous myocardial infarction, documented LVEF must be 55% or greater
Must not have
A history of left ventricular dysfunction prior to index STEMI
Inability to undergo apheresis procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing a new way to treat heart disease by using a combination of gene and cell therapy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't specified here but may include reactions related to cell infusion procedures such as discomfort at injection site or immune responses. Gene therapy risks could involve unintended effects on other genes or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a heart attack in the last 30 days confirmed by an ECG.
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My heart's pumping ability is good after a heart attack.
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My heart and blood circulation are stable.
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I had a successful stent placement in a heart artery within the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had heart muscle weakness before my major heart attack.
Select...
I cannot undergo apheresis.
Select...
I have a history of HIV or hepatitis B/C.
Select...
I am on long-term medication for an autoimmune disease.
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I have a serious heart valve problem that hasn't been fixed.
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I have not had a stroke or mini-stroke in the last 6 months.
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I have a serious heart artery problem.
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I have had cancer within the last 5 years.
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I have had serious heart rhythm problems not caused by my initial heart attack.
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I have undergone cell or gene therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Global LVEF
Secondary study objectives
Assessment of: Cardiac wall motion and volumes
Safety Measurements
Time To Clinical Worsening (TTCW)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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 Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,834 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,386 Previous Clinical Trials
26,515,928 Total Patients Enrolled
Stem Cell NetworkOTHER
8 Previous Clinical Trials
548 Total Patients Enrolled

Media Library

Autologous EPCs (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00936819 — Phase 2
Heart Attack Research Study Groups: Plasma-Lyte A and 25% autologous plasma, Autologous EPCs, Autologous EPCs Transfected with human eNOS
Heart Attack Clinical Trial 2023: Autologous EPCs Highlights & Side Effects. Trial Name: NCT00936819 — Phase 2
Autologous EPCs (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00936819 — Phase 2
~4 spots leftby Nov 2025
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