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

NCT01569178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Anthony Mathur, MD, FRCP, PhD · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2019-11-27
Completion
2019-11-27

Countries

  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569178 on ClinicalTrials.gov