Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)

February 27, 2020 updated by: Anthony Mathur, Barts & The London NHS Trust

Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction

Study hypothesis :

The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.

Aims

  • To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
  • To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
  • To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshopitalet, Unversity of Copenhagen
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • London, United Kingdom
        • The Heart Hosptial, UCLH Foundation Trust
      • London, United Kingdom
        • The Royal Free Hospital, Royal Free London Foundation Trust
    • London
      • Bethnal Green, London, United Kingdom, E2 9JX
        • London Chest Hospital, Barts and The London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
  • Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
  • At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
  • Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
  • Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
  • Written informed consent in the recruiting centres native language

Exclusion Criteria:

  • Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
  • Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
  • Arteriovenous malformations or aneurysms
  • Active infection, or fever or diarrhoea within last 4 weeks
  • Chronic inflammatory disease
  • Known HIV infection or active hepatitis
  • Neoplastic disease without documented remission within the past 5 years
  • Cerebrovascular insult within 3 months
  • Impaired renal function (creatinine > 200mmol) at the time of cell therapy
  • Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
  • Anemia (hemoglobin < 8.5 mg/dl)
  • Platelet count < 100.000/µl
  • Hypersplenism
  • Known allergy or intolerance to clopidogrel, heparin or abciximab
  • History of bleeding disorder
  • Gastrointestinal bleeding within 3 months
  • Major surgical procedure or trauma within 2 months
  • Uncontrolled hypertension
  • Pregnancy
  • Mental retardation leading to inability to obtain informed consent
  • Previously performed stem / progenitor cell therapy
  • Participation in another clinical trial within the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo infusion
Other: Placebo infusion
Placebo infusion
Experimental: Intracoronary
Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
Other: Bone marrow derived progenitor cells or placebo infusion
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Longitudinal change in left ventricular function (ejection fraction)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Time Frame: 3 months
3 months
Longitudinal change in left ventricular function as measured by LV angiography
Time Frame: 6 months
6 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time Frame: 6 months
6 months
Change in left ventricular end systolic volume and change in infarct size.
Time Frame: 12 months
12 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time Frame: 12 months
12 months
MACE
Time Frame: 12 months
12 months
Change in Quality of life
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

University College, London
Queen Mary University of London

Investigators

  • Principal Investigator: Anthony Mathur, FRCP FESC Ph, Barts and the London NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/Q0603/76
  • 2007-002-144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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