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

Sponsor

Queen Mary University of London (Other)

Overall Status

Completed

CT.gov ID

NCT01569178

Collaborator

(none)

375

Enrollment

Locations

Arms

74.8

Duration (Months)

11.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Death	Procedure: Bone Marrow aspiration and intracoronary reinfusion	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

The advanced therapy treatment product used in this trial is open label, hence no masking

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Nov 27, 2019

Actual Study Completion Date :

Nov 27, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time from randomization to all-cause death [for an average of 3 years]

Secondary Outcome Measures

Time from randomization to cardiac death [for an average of 3 years]
time from randomization to cardiovascular rehospitalisation [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
incidence and severity of adverse events [for an average of 3 years]
bleeding by BARC definition [for an average of 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cardiovascular Research Centre VZW	Aalst	Belgium
2	Katholieke Universiteit Leuven	Leuven	Belgium
3	Fakultni Nemocnice BRNO	Brno	Czechia
4	Region Hovedstaden	Copenhagen	Denmark
5	Kuopio University Hospital	Kuopio	Finland
6	Zentralklinik Bad Berka	Bad Berka	Germany
7	Universitätsmedizin Charité Berlin	Berlin	Germany	12203
8	UniLinikum Bonn	Bonn	Germany
9	Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie	Dusseldorf	Germany	40225
10	HELIOS Klinikum Erfurt GmbH	Erfurt	Germany	99089
11	University Hospital Essen	Essen	Germany	45147
12	Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN	Frankfurt	Germany
13	Klinikum Fulda gAG	Fulda	Germany
14	Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med	Greifswald	Germany	17475
15	UKSh Campus Lubeck, Med. Klinik II	Lubeck	Germany	23538
16	Krankenhaus Hetzelstift Neustadt	Neustadt	Germany	67434
17	SRH Zentralklinikum Suhl GmbH	Suhl	Germany
18	University Hospital Ulm, Clinic of Internal Medicine II	Ulm	Germany	89081
19	Universita Cattolica Del Sacro Cuore	Rome	Italy
20	UMC Utrecht	Utrecht	Netherlands	E03-511
21	Hospital Universitario La Princesa	Madrid	Spain	28006
22	Hospital Universitario Clinico San Carlos	Madrid	Spain	28040
23	Fundacion Jimenez Diaz	Madrid	Spain
24	Hospital Universitario Fundacion Alcorcon	Madrid	Spain
25	Servico Madrileno De Salud	Madrid	Spain
26	Hospital Clinico Salamanca	Salamanca	Spain
27	H.U. Marques de Valdecilla	Santander	Spain
28	Hospital Universitario Virgen del Rocio	Sevilla	Spain	41013
29	Hospital Clinico Universitario De Valladolid	Valladolid	Spain
30	Hospiatl Universitatio Miguel Servet	Zaragoza	Spain	50009
31	Cardiocentro Ticino	Lugano	Switzerland	6900
32	Queen Mary, University of London (QMUL)	London	United Kingdom
33	New Cross Hospital, Royal Wolverhampton NHS Trust	Wolverhampton	United Kingdom