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 |
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Recruitment Status :
Completed
First Posted : April 3, 2012
Last Update Posted : April 13, 2021
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Sponsor:
Queen Mary University of London
Information provided by (Responsible Party):
Anthony Mathur, Queen Mary University of London
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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 Type : | Interventional (Clinical Trial) |
| 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 : | September 2013 |
| Actual Primary Completion Date : | November 27, 2019 |
| Actual Study Completion Date : | November 27, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Attack
| Arm | Intervention/treatment |
|---|---|
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No Intervention: standard care
optimal standard care post myocardial infarction
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Experimental: Intracoronary Reinfusion of Cells
Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
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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 :
- Time from randomization to all-cause death [ Time Frame: for an average of 3 years ]
Secondary Outcome Measures :
- 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 ]
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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
Locations
Show 33 study locations
Sponsors and Collaborators
Queen Mary University of London
Investigators
| Principal Investigator: | Anthony Mathur, MD, FRCP, PhD | Queen Mary University of London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthony Mathur, Clinical Director, Queen Mary University of London |
| ClinicalTrials.gov Identifier: | NCT01569178 |
| Other Study ID Numbers: |
BAMI-01 |
| First Posted: | April 3, 2012 Key Record Dates |
| Last Update Posted: | April 13, 2021 |
| Last Verified: | April 2021 |
| 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:
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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 |