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

Myocardial Infarction Clinical Trial

— BAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569178
• Other study ID #: BAMI-01
• Status: Completed
• Phase: Phase 3
• Start date: September 2013
• Est. completion date: November 27, 2019

Study information

• Verified date: April 2021
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Belgium	Cardiovascular Research Centre VZW	Aalst
Belgium	Katholieke Universiteit Leuven	Leuven
Czechia	Fakultni Nemocnice BRNO	Brno
Denmark	Region Hovedstaden	Copenhagen
Finland	Kuopio University Hospital	Kuopio
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Universitätsmedizin Charité Berlin	Berlin
Germany	UniLinikum Bonn	Bonn
Germany	Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie	Dusseldorf
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	Lubeck
Germany	Krankenhaus Hetzelstift Neustadt	Neustadt
Germany	SRH Zentralklinikum Suhl GmbH	Suhl
Germany	University Hospital Ulm, Clinic of Internal Medicine II	Ulm
Italy	Universita Cattolica Del Sacro Cuore	Rome
Netherlands	UMC Utrecht	Utrecht
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario Fundacion Alcorcon	Madrid
Spain	Hospital Universitario La Princesa	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	Sevilla
Spain	Hospital Clinico Universitario De Valladolid	Valladolid
Spain	Hospiatl Universitatio Miguel Servet	Zaragoza
Switzerland	Cardiocentro Ticino	Lugano
United Kingdom	Queen Mary, University of London (QMUL)	London
United Kingdom	New Cross Hospital, Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to all-cause death		for an average of 3 years
Secondary	Time from randomization to cardiac death		for an average of 3 years
Secondary	time from randomization to cardiovascular rehospitalisation	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
Secondary	incidence and severity of adverse events		for an average of 3 years
Secondary	bleeding by BARC definition		for an average of 3 years