Myocardial InfarctionPhase 3BAMINCT01569178
BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
A Phase 3 study testing Bone Marrow aspiration and intracoronary reinfusion in people with Myocardial Infarction and Death, run by Queen Mary University of London at 33 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Death
- What is being tested?
- Bone Marrow aspiration and intracoronary reinfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 33 sitesin 10 countries
- Study dates
- Sep 2013to 27 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
Germany13 sites
Zentralklinik Bad Berka
Bad Berka
Universitätsmedizin Charité Berlin
Berlin, 12203
UniLinikum Bonn
Bonn
Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225
HELIOS Klinikum Erfurt GmbH
Erfurt, 99089
University Hospital Essen
Essen, 45147
Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN
Frankfurt
Klinikum Fulda gAG
Fulda
Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med
Greifswald, 17475
UKSh Campus Lubeck, Med. Klinik II
Lübeck, 23538
Krankenhaus Hetzelstift Neustadt
Neustadt, 67434
SRH Zentralklinikum Suhl GmbH
Suhl
University Hospital Ulm, Clinic of Internal Medicine II
Ulm, 89081
Spain10 sites
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Clinico San Carlos
Madrid, 28040
Fundacion Jimenez Diaz
Madrid
Hospital Universitario Fundacion Alcorcon
Madrid
Servico Madrileno De Salud
Madrid
Hospital Clinico Salamanca
Salamanca
H.U. Marques de Valdecilla
Santander
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario De Valladolid
Valladolid
Hospiatl Universitatio Miguel Servet
Zaragoza, 50009
Belgium2 sites
Cardiovascular Research Centre VZW
Aalst
Katholieke Universiteit Leuven
Leuven
United Kingdom2 sites
Queen Mary, University of London (QMUL)
London
New Cross Hospital, Royal Wolverhampton NHS Trust
Wolverhampton
About this study
Official title: The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
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.
- Conditions
- Myocardial Infarction, Death
- Being tested
- Bone Marrow aspiration and intracoronary reinfusion
- Keywords
- stem cells, acute myocardial infarction, heart failure, heart attack, bone marrow, intracoronary reinfusion, bone marrow derived mononuclear cells, Left ventricular function improvement, mortality
- Medical subject headings
- Myocardial Infarction, Death, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow aspiration and intracoronary reinfusionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| standard care | No intervention | optimal standard care post myocardial infarction |
| Intracoronary Reinfusion of Cells | Experimental | Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells Receives: Procedure: Bone Marrow aspiration and intracoronary reinfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to all-cause death
Measured: for an average of 3 years
Secondary outcomes (4)
Time from randomization to cardiac death
Measured: for an average of 3 years
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
Measured: for an average of 3 years
incidence and severity of adverse events
Measured: for an average of 3 years
bleeding by BARC definition
Measured: for an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startSep 2013
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Mathur, Queen Mary University of London
- Investigators
- Anthony Mathur, MD, FRCP, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569178
- Sponsor's protocol ID
- BAMI-01
- Acronym
- BAMI
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2012
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28948706
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT01569178
- Acronym / sponsor ID
- BAMI / BAMI-01
- Conditions
- Myocardial Infarction, Death
- Keywords
- stem cells, acute myocardial infarction, heart failure, heart attack, bone marrow, intracoronary reinfusion, bone marrow derived mononuclear cells, Left ventricular function improvement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –optimal standard care post myocardial infarction |
| Intracoronary Reinfusion of Cells | Experimental | Procedure: Bone Marrow aspiration and intracoronary reinfusionBone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow aspiration and intracoronary reinfusionBone 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 | Procedure or surgery | Intracoronary Reinfusion of Cells |
Primary outcome
Time from randomization to all-cause death
Time frame: for an average of 3 years
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 28948706Mathur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mathur, MD, FRCP, PhD principal investigator
Queen Mary University of London
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone Marrow aspiration and intracoronary reinfusion in people with Myocardial Infarction and Death, run by Queen Mary University of London at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Spain, Belgium, United Kingdom, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to all-cause death (time frame: for an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.