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

NCT ID: NCT01569178

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-11-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care

optimal standard care post myocardial infarction

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intracoronary Reinfusion of Cells

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

Group Type: EXPERIMENTAL

Bone Marrow aspiration and intracoronary reinfusion

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Anthony Mathur

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Mathur, MD, FRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Cardiovascular Research Centre VZW

Aalst, , Belgium

Katholieke Universiteit Leuven

Leuven, , Belgium

Fakultni Nemocnice BRNO

Brno, , Czechia

Region Hovedstaden

Copenhagen, , Denmark

Kuopio University Hospital

Kuopio, , Finland

Zentralklinik Bad Berka

Bad Berka, , Germany

Universitätsmedizin Charité Berlin

Berlin, , Germany

UniLinikum Bonn

Bonn, , Germany

Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie

Düsseldorf, , Germany

HELIOS Klinikum Erfurt GmbH

Erfurt, , Germany

University Hospital Essen

Essen, , Germany

Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN

Frankfurt, , Germany

Klinikum Fulda gAG

Fulda, , Germany

Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med

Greifswald, , Germany

UKSh Campus Lubeck, Med. Klinik II

Lübeck, , Germany

Krankenhaus Hetzelstift Neustadt

Neustadt, , Germany

SRH Zentralklinikum Suhl GmbH

Suhl, , Germany

University Hospital Ulm, Clinic of Internal Medicine II

Ulm, , Germany

Universita Cattolica Del Sacro Cuore

Rome, , Italy

UMC Utrecht

Utrecht, , Netherlands

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario Clinico San Carlos

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Fundacion Alcorcon

Madrid, , Spain

Servico Madrileno De Salud

Madrid, , Spain

Hospital Clinico Salamanca

Salamanca, , Spain

H.U. Marques de Valdecilla

Santander, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Clinico Universitario De Valladolid

Valladolid, , Spain

Hospiatl Universitatio Miguel Servet

Zaragoza, , Spain

Cardiocentro Ticino

Lugano, , Switzerland

Queen Mary, University of London (QMUL)

London, , United Kingdom

New Cross Hospital, Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 28948706 (View on PubMed)

Other Identifiers

BAMI-01

Identifier Type: -

Identifier Source: org_study_id