BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction (BAMI)

April 8, 2021 updated by: Anthony Mathur, Queen Mary University of London

The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.

This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

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

  • Belgium
      • Aalst, Belgium
        • Cardiovascular Research Centre VZW
      • Leuven, Belgium
        • Katholieke Universiteit Leuven
  • Czechia
      • Brno, Czechia
        • Fakultni nemocnice Brno
  • Denmark
      • Copenhagen, Denmark
        • Region Hovedstaden
  • Finland
      • Kuopio, Finland
        • Kuopio University Hospital
  • Germany
      • Bad Berka, Germany
        • Zentralklinik Bad Berka
      • Berlin, Germany, 12203
        • Universitätsmedizin Charité Berlin
      • Bonn, Germany
        • UniLinikum Bonn
      • Dusseldorf, Germany, 40225
        • Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt GmbH
      • Essen, Germany, 45147
        • University Hospital Essen
      • Frankfurt, Germany
        • Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN
      • Fulda, Germany
        • Klinikum Fulda gAG
      • Greifswald, Germany, 17475
        • Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med
      • Lubeck, Germany, 23538
        • UKSh Campus Lubeck, Med. Klinik II
      • Neustadt, Germany, 67434
        • Krankenhaus Hetzelstift Neustadt
      • Suhl, Germany
        • SRH Zentralklinikum Suhl GmbH
      • Ulm, Germany, 89081
        • University Hospital Ulm, Clinic of Internal Medicine II
  • Italy
      • Rome, Italy
        • Università Cattolica del Sacro Cuore
  • Netherlands
      • Utrecht, Netherlands, E03-511
        • UMC Utrecht
  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario Fundación Alcorcón
      • Madrid, Spain
        • Servico Madrileno De Salud
      • Salamanca, Spain
        • Hospital Clinico Salamanca
      • Santander, Spain
        • H.U. Marqués de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospiatl Universitatio Miguel Servet
  • Switzerland
      • Lugano, Switzerland, 6900
        • Cardiocentro Ticino
  • United Kingdom
      • London, United Kingdom
        • Queen Mary, University of London (QMUL)
      • Wolverhampton, United Kingdom
        • New Cross Hospital, Royal Wolverhampton 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • signed and dated informed consent form
  • men and women of any ethnic origin aged≥18years
  • patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB)
  • Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
  • Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis
  • Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 2 to 6 days after reperfusion therapy
  • Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

Exclusion Criteria:

  • Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting
  • Previously received stem/progenitor cell therapy
  • Pregnant or nursing women
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
  • Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time.
  • Cardiogenic shock requiring mechanical support
  • Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
  • Impaired renal function, i.e. creatinine >2.5 mg/dl
  • Fever or diarrhoea not responsive to treatment within 4 weeks prior screening
  • Cliinically significant bleeding disorder within 3 months prior screening
  • Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
  • Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
optimal standard care post myocardial infarction
Experimental: Intracoronary Reinfusion of Cells
Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
Procedure: Bone Marrow aspiration and intracoronary reinfusion
Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to all-cause death
Time Frame: for an average of 3 years
for an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomization to cardiac death
Time Frame: for an average of 3 years
for an average of 3 years
time from randomization to cardiovascular rehospitalisation
Time Frame: for an average of 3 years
time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias
for an average of 3 years
incidence and severity of adverse events
Time Frame: for an average of 3 years
for an average of 3 years
bleeding by BARC definition
Time Frame: for an average of 3 years
for an average of 3 years

Collaborators and Investigators

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

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Anthony Mathur, MD, FRCP, PhD, Queen Mary University of London

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

September 1, 2013

Primary Completion (Actual)

November 27, 2019

Study Completion (Actual)

November 27, 2019

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAMI-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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