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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 (BAMI)

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ClinicalTrials.gov Identifier: NCT01569178
Recruitment Status : Recruiting
First Posted : April 3, 2012
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Anthony Mathur, Queen Mary University of London

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : September 2013
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  1. Time from randomization to all-cause death [ Time Frame: for an average of 3 years ]

Secondary Outcome Measures :
  1. Time from randomization to cardiac death [ Time Frame: for an average of 3 years ]
  2. time from randomization to cardiovascular rehospitalisation [ Time Frame: 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

  3. incidence and severity of adverse events [ Time Frame: for an average of 3 years ]
  4. bleeding by BARC definition [ Time Frame: for an average of 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569178


Contacts
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Contact: Anthony Mathur, MB BChir, FRCP, PhD (+44) 2037658738 a.mathur@qmul.ac.uk

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Locations
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Belgium
Cardiovascular Research Centre VZW Recruiting
Aalst, Belgium
Principal Investigator: Jozef Bartunek         
Katholieke Universiteit Leuven Recruiting
Leuven, Belgium
Principal Investigator: Stefan Janssens         
Czechia
Fakultni Nemocnice BRNO Recruiting
Brno, Czechia
Principal Investigator: Petr Kala         
Denmark
Region Hovedstaden Recruiting
Copenhagen, Denmark
Principal Investigator: Jens Kastrup         
Finland
Ita-Suomen Yliopisto Not yet recruiting
Kuopio, Finland
Principal Investigator: Seppo Yla-Herttuala         
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Seppo Yla-Herttuala, MD,Phd         
France
Assitance Publique - Hopitaux de Paris Not yet recruiting
Paris, France
Principal Investigator: Philippe Menasche         
Germany
Zentralklinik Bad Berka Recruiting
Bad Berka, Germany
Principal Investigator: Marc Ohlow         
Universitätsmedizin Charité Berlin Recruiting
Berlin, Germany, 12203
Contact: David-Manuel Leistner         
St Josef - Hospital de Ruhr - Uni Bochum Recruiting
Bochum, Germany, 44791
Contact: Andreas Muegge         
UniLinikum Bonn Recruiting
Bonn, Germany
Principal Investigator: Nicolas Werner, MD         
Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie Recruiting
Dusseldorf, Germany, 40225
Contact: Tobias Zeus, MD         
HELIOS Klinikum Erfurt GmbH Recruiting
Erfurt, Germany, 99089
Contact: Harald Lapp, PhD         
University Hospital Essen Recruiting
Essen, Germany, 45147
Contact: Rassaf, PhD         
Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN Recruiting
Frankfurt, Germany
Principal Investigator: Andreas Zeiher         
Klinikum Fulda gAG Recruiting
Fulda, Germany
Principal Investigator: V. Schachinger         
Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med Recruiting
Greifswald, Germany, 17475
Contact: Stephan B Felix, MD         
Cardiologicum Hamburg Asklepiosklinik Hamburg - Wandsbek Recruiting
Hamburg, Germany
Principal Investigator: Dirk Walter         
Medizinische Hochschule Hannover (MHH) Not yet recruiting
Hannover, Germany
Principal Investigator: Kai Wollert         
UKSh Campus Lubeck, Med. Klinik II Recruiting
Lubeck, Germany, 23538
Contact: Holger Thiele, MD, PhD         
Krankenhaus Hetzelstift Neustadt Recruiting
Neustadt, Germany, 67434
Contact: Hubertus V Korn         
SRH Zentralklinikum Suhl GmbH Recruiting
Suhl, Germany
Principal Investigator: Werner Haberbosch         
University Hospital Ulm, Clinic of Internal Medicine II Recruiting
Ulm, Germany, 89081
Contact: Jochen Woehrle, MD         
Italy
Universita Cattolica Del Sacro Cuore Recruiting
Rome, Italy
Principal Investigator: Filippo Crea         
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, E03-511
Contact: Steven AJ Chamuleau, MD, PhD         
Poland
Slaski Uniwersytet Medyczny w Katowicach Not yet recruiting
Katowice, Poland
Principal Investigator: Michal Tendera         
Spain
Institut Català de la Salut Not yet recruiting
Barcelona, Spain
Principal Investigator: Manuel Galinanes         
Hospital Universitario La Princesa Recruiting
Madrid, Spain, 28006
Principal Investigator: Amparo Benedicto         
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Principal Investigator: Pilar Jiménez Quevedo         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain, 28222
Principal Investigator: Luis Alonso Pulpón         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain
Principal Investigator: Jeronimo Farre         
Hospital Universitario Fundacion Alcorcon Recruiting
Madrid, Spain
Principal Investigator: Javier Botas Rodriguez         
Servico Madrileno De Salud Recruiting
Madrid, Spain
Principal Investigator: Francisco Fernandez-Aviles         
Hospital Clinico Salamanca Recruiting
Salamanca, Spain
Principal Investigator: Pedro Luis Sanchez Fernandez         
H.U. Marques de Valdecilla Recruiting
Santander, Spain
Contact: Jose MDLT Hernandez       he1thj@humv.es   
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Principal Investigator: Luis Diaz de la Llera         
Hospital Clinico Universitario De Valladolid Recruiting
Valladolid, Spain
Principal Investigator: Jose Alberto San Roman Calvar         
Hospiatl Universitatio Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Rosaria Ortas Nadal, MD         
Switzerland
Cardiocentro Recruiting
Ticino, Switzerland, 6900
Contact: Tiziano Moccetti, PhD         
United Kingdom
King's College London (KCL) Not yet recruiting
London, United Kingdom
Principal Investigator: Jonathan Hill         
Queen Mary, University of London (QMUL) Recruiting
London, United Kingdom
University College London (UCL) Not yet recruiting
London, United Kingdom
Principal Investigator: John Martin         
New Cross Hospital, Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, United Kingdom
Principal Investigator: James Cotton         
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Anthony Mathur, MD, FRCP, PhD Queen Mary University of London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anthony Mathur, Clinical Director, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01569178     History of Changes
Other Study ID Numbers: BAMI-01
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Mathur, Queen Mary University of London:
stem cells
acute myocardial infarction
heart failure
heart attack
bone marrow
intracoronary reinfusion
bone marrow derived mononuclear cells
Left ventricular function improvement
mortality
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases