NCT00936819

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
42mo left

Started Jul 2013

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2013Nov 2029

First Submitted

Initial submission to the registry

July 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
4 years until next milestone

Study Start

First participant enrolled

July 19, 2013

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Expected
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

6.6 years

First QC Date

July 7, 2009

Last Update Submit

August 12, 2025

Conditions

Anterior Wall Myocardial Infarction

Keywords

Stentendothelial progenitor cellsnitric oxidemyocardial infarctionMRI

Outcome Measures

Primary Outcomes (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.

    Baseline to 6 months

Secondary Outcomes (3)

  • Assessment of: Cardiac wall motion and volumes

    Baseline to 6 months

  • Time To Clinical Worsening (TTCW)

    Baseline to 6 months

  • Safety Measurements

    Baseline to 6 months

Study Arms (3)

Plasma-Lyte A and 25% autologous plasma

PLACEBO COMPARATOR

A single dose of Plasma-Lyte A in Human Albumin 2.5% total = 8 mL of study product delivered into the Infarct Related Artery

Biological: Plasma-Lyte A and 25% Autologous Plasma

Autologous EPCs

EXPERIMENTAL

A 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

Biological: Autologous EPCs

Autologous EPCs Transfected with human eNOS

EXPERIMENTAL

A 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

Biological: Autologous EPCs Transfected with human eNOS

Interventions

Plasma-Lyte A and 25% Autologous PlasmaBIOLOGICAL

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

Plasma-Lyte A and 25% autologous plasma
Autologous EPCsBIOLOGICAL

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

Also known as: Non-applicable
Autologous EPCs
Autologous EPCs Transfected with human eNOSBIOLOGICAL

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

Also known as: Non-applicable
Autologous EPCs Transfected with human eNOS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

L'institut de cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionMyocardial Infarction

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Duncan Stewart, MD, FRCP C

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 10, 2009

Study Start

July 19, 2013

Primary Completion

March 5, 2020

Study Completion (Estimated)

November 1, 2029

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

CA(3)