Acute and Severe Myocardial InfarctionPhase 2NCT00200707
BONAMI (BOne Marrow in Acute Myocardial Infarction)
A Phase 2 study testing Intracoronary injection of autologous bone marrow mononuclear cells in people with Acute and Severe Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
Trial summary
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute and Severe Myocardial Infarction
- What is being tested?
- Intracoronary injection of autologous bone marrow mononuclear cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Apr 2009
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18-75 years.
- Acute myocardial infarction
- Absence of viability in the infarcted zone and LVEF <45%.
Who cannot join
- History of prior myocardial infarction
- Significant stenosis in another coronary territory than the acutely treated vessel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.
Read the detailed description
After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.
- Conditions
- Acute and Severe Myocardial Infarction
- Being tested
- Intracoronary injection of autologous bone marrow mononuclear cells
- Keywords
- Cell therapy, bone marrow mononuclear cells, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary injection of autologous bone marrow mononuclear cellsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| The treatment group | Experimental | Intracoronary Injection of Autologous Bone Marrow Mononuclear C Receives: Procedure: Intracoronary injection of autologous bone marrow mononuclear cells |
| the control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
Measured: after 3 months and 1 year of treatment
Secondary outcomes (2)
Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)
Measured: after 1,3,6 ,12 months of treatment
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute and Severe Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia LEMARCHAND, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200707
- Sponsor's protocol ID
- BRD/03/2-B
- Status last verified
- Apr 2014
- First submitted
- 13 Sep 2005
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Manrique A, Lemarchand P, Delasalle B, Lairez O, Sportouch-Duckan C, Lamirault G, Le Corvoisier P, Neuder Y, Richardson M, Lebon A, Roncalli J, Piot C, Trochu JN, Teiger E, Hossein-Foucher C, Le Tourneau T. Predictors of ventricular remodelling in patients with reperfused acute myocardial infarction and left ventricular dysfunction candidates for bone marrow cell therapy: insights from the BONAMI trial. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):740-8. doi: 10.1007/s00259-015-3279-z. Epub 2015 Dec 15.
PubMed 26666236Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
PubMed 21127322
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00200707
- Acronym / sponsor ID
- BRD/03/2-B
- Conditions
- Acute and Severe Myocardial Infarction
- Keywords
- Cell therapy, bone marrow mononuclear cells, myocardial infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Sep 2005 (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.
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.
Detailed description
After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The treatment group | Experimental | Procedure: Intracoronary injection of autologous bone marrow mononuclear cellsIntracoronary Injection of Autologous Bone Marrow Mononuclear C |
| the control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women between 18-75 years.
- Acute myocardial infarction
- Absence of viability in the infarcted zone and LVEF <45%.
Key exclusion criteria (2 listed)
- History of prior myocardial infarction
- Significant stenosis in another coronary territory than the acutely treated vessel
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 |
|---|---|---|
| Intracoronary injection of autologous bone marrow mononuclear cells | Procedure or surgery | The treatment group |
Primary outcome
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
Time frame: after 3 months and 1 year of treatment
2 secondary outcomes
Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)
Time frame: after 1,3,6 ,12 months of treatment
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection
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 30 Apr 2014.
- Derived from this study: PubMed 26666236Manrique A, Lemarchand P, Delasalle B, Lairez O, Sportouch-Duckan C, Lamirault G, Le Corvoisier P, Neuder Y, Richardson M, Lebon A, Roncalli J, Piot C, Trochu JN, Teiger E, Hossein-Foucher C, Le Tourneau T. Predictors of ventricular remodelling in patients with reperfused acute myocardial infarction and left ventricular dysfunction candidates for bone marrow cell therapy: insights from the BONAMI trial. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):740-8. doi: 10.1007/s00259-015-3279-z. Epub 2015 Dec 15.
- Derived from this study: PubMed 21127322Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
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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.
Patricia LEMARCHAND, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intracoronary injection of autologous bone marrow mononuclear cells in people with Acute and Severe Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 2 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 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (time frame: after 3 months and 1 year of treatment). 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 NCT00200707, which also lists 2 linked publications.
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 30 Apr 2014.