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Anterior Wall Myocardial InfarctionPhase 2ENACT-AMINCT00936819

The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction Trial

A Phase 2 study testing Plasma-Lyte A and 25% Autologous Plasma, Autologous EPCs and Autologous EPCs Transfected with human eNOS in people with Anterior Wall Myocardial Infarction, run by Ottawa Hospital Research Institute at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anterior Wall Myocardial Infarction
What is being tested?
Plasma-Lyte A and 25% Autologous Plasma, Autologous EPCs and Autologous EPCs Transfected with human eNOS
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
3 sitesCanada
Study dates
19 Jul 2013to Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18-80 years of age
  • Clinical diagnosis of anterior ST-elevation myocardial infarction within the last 30 days, with any one of the following 12-lead electrocardiographic changes:
  • a) Greater than or equal to 1 mm ST elevation or new Q waves in 2 adjacent electrocardiographic precordial leads
  • b) A new left bundle branch block AND and for patients presenting within 3 days of onset of chest pain an increase in cardiospecific enzymes (>3x CK with, EITHER positive MB fraction or increase in troponin compared to institution laboratory normal ranges)
  • Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, TIMI flow of at least 2 or greater and a reference diameter of at least > 2mm
  • Is considered hemodynamically stable at time of enrollment and immediately prior to cell delivery
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  • Screening LVEF must be no greater than 45% by echocardiography (determined by Simpson's method) performed at least 4 days after revascularization procedure. (All screening echos done within the first 4 days post-PCI must be repeated either by echocardiography or MRI prior to cell delivery to ensure that the variability does not exceed 10%)
  • In the case of a previous myocardial infarction, documented LVEF must be 55% or greater
  • Female participants MUST be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state
  • Provided written informed consent and is willing to comply with study follow-up visits

Who cannot join

  • Significant unprotected left main disease (stenosis of 50% or greater on diagnostic angiography)
  • An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments
  • The presence of significant coronary lesions, other than the index lesion of the IRA
  • A history of significant ventricular arrhythmia NOT related to index STEMI
  • A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment
  • Meets at least one exclusion criterion for MRI (NB: Recent stent implantation is not an exclusion)
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  • Inability to undergo apheresis procedure (i.e.: poor venous access, laboratory abnormalities)
  • A history of uncorrected significant valvular heart disease
  • A history of left ventricular dysfunction prior to index STEMI
  • A history of human immunodeficiency virus (HIV) or hepatitis B or C infection
  • A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer)
  • A history of allergy to gentamycin or amphotericin
  • A history of Heparin-Induced Thrombocytopenia (HIT)
  • A history of non-compliance
  • Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy
  • Creatinine clearance <60 by Cockcroft-Gault Calculator
  • Confirmed pregnant or lactating
  • Is enrolled in a current investigational drug or device trial
  • Participant has received cell or gene therapy in past
  • The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial
  • Inability to provide informed consent and comply with the follow-up visit schedule

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • L'institut de cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: A Phase IIb, Randomized, Double-blind, Placebo Controlled Study Using Transplantation of Autologous Early Endothelial Progenitor Cells(EPCs) for Patients Who Have Suffered Acute Myocardial Infarction

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.

Read the detailed description

Introduction:

  • Despite the widespread use of pharmacological and/or interventional reperfusion therapies, recovery of cardiac function in myocardial infarction patients is often modest or in some cases absent. Unlike classical re-perfusion therapies, which must be delivered before irreversible cardiac damage has occurred, the use of progenitor cells could potentially restore functional tissue in regions that otherwise would form only scar. A number of clinical trials have been performed, mainly using autologous bone marrow cells, and these suggest a significant albeit modest improvement in cardiac function post MI. However, a major limitation of autologous cell therapy in patients with cardiovascular disease is the deleterious influence of age and other cardiac risk factors on progenitor cell activity, which may limit greatly the potential efficacy of this promising approach.

Trial Design:

  • The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction (ENACT-AMI) trial is a Canadian, 5-center, phase IIb, double-blind, parallel, randomized placebo controlled trial assessing the safety and efficacy of cell and gene therapy for patients with moderate to large anterior STEMI and who have undergone re-vascularization with stent implantation to the infarct related artery (IRA). The anticipated recruitment target is 100 patients over a two-year period.
  • Consenting participants who qualify during the screening process, will undergo apheresis. Randomization, through a web-based system will take place immediately after successful apheresis. The cell collection samples will be sent to a cell manufacturing facility for manufacturing according to the treatment allocation of: a)Placebo (Plasma-Lyte A \& 25% autologous plasma), b)EPCs or c)EPCs transfected with human endothelial nitric oxide synthase (eNOS).
  • Approximately 5-7 days later, the patient will receive the randomized treatment allocation via intracoronary injection into the IRA. Participants will remain in hospital overnight for continuous cardiac monitoring. The first post-delivery visit will take place the following morning before hospital discharge. Subsequent study visits will be clinic visits at 1 week, 1, 3 and 6 months after study treatment. Subsequently, a registry to collect long-term safety information from telephone contacts will continue annually for 10 years. During the registry period, participants will be allowed to volunteer for enrolment in other clinical trials.
Being tested
Plasma-Lyte A and 25% Autologous Plasma, Autologous EPCs, Autologous EPCs Transfected with human eNOS
Keywords
Stent, endothelial progenitor cells, nitric oxide, myocardial infarction, MRI
Medical subject headings
Anterior Wall Myocardial Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plasma-Lyte A and 25% Autologous PlasmaBiological

    Single dose of 8 mls given by investigator via intracoronary injection into stent of infarct-related artery

  • Autologous EPCsBiological

    Also called Non-applicable

    Single dose of 20 million cells in 8 mls given by investigator via intracoronary injection into stent of infarct-related artery

  • Autologous EPCs Transfected with human eNOSBiological

    Also called Non-applicable

    Single dose of 20 million cells in 8 mls given by investigator via intracoronary injection into stent of infarct-related artery

Study groups in NCT00936819
Study groupRoleWhat they receive
Plasma-Lyte A and 25% autologous plasmaPlacebo comparatorA single dose of Plasma-Lyte A in Human Albumin 2.5% total = 8 mL of study product delivered into the Infarct Related Artery
Receives: Biological: Plasma-Lyte A and 25% Autologous Plasma
Autologous EPCsExperimentalA single dose of 20 million Autologous non-transfected Endothelial Progenitor Cells in Human Albumin 2.5% total = 8 mL of study product delivered into the Infarct Related Artery
Receives: Biological: Autologous EPCs
Autologous EPCs Transfected with human eNOSExperimentalA single dose of 20 million Autologous transfected with human eNOS (endothelial nitric oxide synthase) Endothelial Progenitor Cells in Human Albumin 2.5% total = 8 mL of study product delivered into the Infarct Related Artery
Receives: Biological: Autologous EPCs Transfected with human eNOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Global LVEF

    1. A change in global left ventricular ejection fraction by cardiac MRI between those treated with cell/gene enriched EPCs versus placebo
    2. Change in global left ventricular ejection fraction by cardiac MRI between those treated with non-transfected autologous EPCs versus eNOS transfected EPCs.

    Measured: Baseline to 6 months

Secondary outcomes (3)

  1. Assessment of: Cardiac wall motion and volumes

    1. Change in regional wall motion and regional wall thickening by cardiac MRI between the above patient groups
    2. Change in echocardiographic assessment of LVEF, infarct size and ventricular volumes between the above patient groups

    Measured: Baseline to 6 months

  2. Time To Clinical Worsening (TTCW)

    Quality of Life Measures: Participants will complete SF-36 and DASI questionnaires at baseline, 3 and 6 months.

    Measured: Baseline to 6 months

  3. Safety Measurements

    1. Clinically significant changes in CK and troponin more than 24 hours post delivery
    2. Clinically significant changes in ECG
    3. Assessment of major acute cardiac events
    4. Evidence of any systemic embolization during the hospitalization period
    5. Need for revacularization procedures

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2009 (estimated)
  2. Study start19 Jul 2013
  3. Primary completion5 Mar 2020
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00936819
Sponsor's protocol ID
2008-872
Other IDs
ISRCTN47943321
Acronym
ENACT-AMI
Status last verified
Aug 2025
First submitted
7 Jul 2009
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plasma-Lyte A and 25% Autologous Plasma, Autologous EPCs and Autologous EPCs Transfected with human eNOS in people with Anterior Wall Myocardial Infarction, run by Ottawa Hospital Research Institute at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Global LVEF (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00936819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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