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

NCT01569178 | Completed Phase 3 DMC

• 1 other identifier: BAMI-01
• Study Type: interventional
• Target: 375
• Locations: 10 countries
• Sites: 33

Brief 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

Myocardial Infarction; Death

Keywords

stem cells; acute myocardial infarction; heart failure; heart attack; bone marrow; intracoronary reinfusion; bone marrow derived mononuclear cells; Left ventricular function improvement; mortality

Outcome Measures

Primary Outcomes (1)

• Time from randomization to all-cause death

  for an average of 3 years

Secondary Outcomes (4)

• Time from randomization to cardiac death

  for an average of 3 years

• time from randomization to cardiovascular rehospitalisation

  for an average of 3 years

• incidence and severity of adverse events

  for an average of 3 years

• bleeding by BARC definition

  for an average of 3 years

Study Arms (2)

standard care

NO INTERVENTION

optimal standard care post myocardial infarction

Intracoronary Reinfusion of Cells

EXPERIMENTAL

Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells

Procedure: Bone Marrow aspiration and intracoronary reinfusion

Interventions

Bone Marrow aspiration and intracoronary reinfusion PROCEDURE

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

Intracoronary Reinfusion of Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (33)

Cardiovascular Research Centre VZW

Aalst, Belgium

Location

Katholieke Universiteit Leuven

Leuven, Belgium

Location

Fakultni Nemocnice BRNO

Brno, Czechia

Location

Region Hovedstaden

Copenhagen, Denmark

Location

Kuopio University Hospital

Kuopio, Finland

Location

Zentralklinik Bad Berka

Bad Berka, Germany

Location

Universitätsmedizin Charité Berlin

Berlin, 12203, Germany

Location

UniLinikum Bonn

Bonn, Germany

Location

Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie

Düsseldorf, 40225, Germany

Location

HELIOS Klinikum Erfurt GmbH

Erfurt, 99089, Germany

Location

University Hospital Essen

Essen, 45147, Germany

Location

Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN

Frankfurt, Germany

Location

Klinikum Fulda gAG

Fulda, Germany

Location

Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med

Greifswald, 17475, Germany

Location

UKSh Campus Lubeck, Med. Klinik II

Lübeck, 23538, Germany

Location

Krankenhaus Hetzelstift Neustadt

Neustadt, 67434, Germany

Location

SRH Zentralklinikum Suhl GmbH

Suhl, Germany

Location

University Hospital Ulm, Clinic of Internal Medicine II

Ulm, 89081, Germany

Location

Universita Cattolica Del Sacro Cuore

Rome, Italy

Location

UMC Utrecht

Utrecht, E03-511, Netherlands

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Universitario Fundacion Alcorcon

Madrid, Spain

Location

Servico Madrileno De Salud

Madrid, Spain

Location

Hospital Clinico Salamanca

Salamanca, Spain

Location

H.U. Marques de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario De Valladolid

Valladolid, Spain

Location

Hospiatl Universitatio Miguel Servet

Zaragoza, 50009, Spain

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Queen Mary, University of London (QMUL)

London, United Kingdom

Location

New Cross Hospital, Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

Related Publications (1)

• Mathur A, Arnold R, Assmus B, Bartunek J, Belmans A, Bonig H, Crea F, Dimmeler S, Dowlut S, Fernandez-Aviles F, Galinanes M, Garcia-Dorado D, Hartikainen J, Hill J, Hogardt-Noll A, Homsy C, Janssens S, Kala P, Kastrup J, Martin J, Menasche P, Miklik R, Mozid A, San Roman JA, Sanz-Ruiz R, Tendera M, Wojakowski W, Yla-Herttuala S, Zeiher A. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial. Eur J Heart Fail. 2017 Nov;19(11):1545-1550. doi: 10.1002/ejhf.829. Epub 2017 Sep 25.

  PMID: 28948706 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Death; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Anthony Mathur, MD, FRCP, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The advanced therapy treatment product used in this trial is open label, hence no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 3, 2012
• Study Start: September 1, 2013
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

GB (2); CZ (1); IT (1); BE (2); DE (13); FI (1); ES (10); NL (1); CH (1); DK (1)