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

• ClinicalTrials.gov Identifier: NCT01569178
• Recruitment Status: Completed
• First Posted: April 3, 2012
• Last Update Posted: April 13, 2021
• Sponsor: Queen Mary University of London
• Information provided by (Responsible Party): Anthony Mathur, Queen Mary University of London

Tracking Information

• First Submitted Date: March 30, 2012
• First Posted Date: April 3, 2012
• Last Update Posted Date: April 13, 2021
• Study Start Date: September 2013
• Actual Primary Completion Date: November 27, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 2, 2012): Time from randomization to all-cause death [ Time Frame: for an average of 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 2, 2012)

• Time from randomization to cardiac death [ Time Frame: for an average of 3 years ]
• 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
• incidence and severity of adverse events [ Time Frame: for an average of 3 years ]
• bleeding by BARC definition [ Time Frame: for an average of 3 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
• Official Title: The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

Condition

• Myocardial Infarction
• Death

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

Study Arms

• 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
  Intervention: Procedure: Bone Marrow aspiration and intracoronary reinfusion

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2021): 375
• Original Estimated Enrollment (submitted: April 2, 2012): 3000
• Actual Study Completion Date: November 27, 2019
• Actual Primary Completion Date: November 27, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
• Removed Location Countries: Czech Republic, France, Norway, Poland

Administrative Information

• NCT Number: NCT01569178
• Other Study ID Numbers: BAMI-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anthony Mathur, Queen Mary University of London
• Original Responsible Party: Barts & The London NHS Trust
• Current Study Sponsor: Queen Mary University of London
• Original Study Sponsor: Barts & The London NHS Trust
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anthony Mathur, MD, FRCP, PhD; Queen Mary University of London

• PRS Account: Queen Mary University of London
• Verification Date: April 2021