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BONAMI (BOne Marrow in Acute Myocardial Infarction)

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ClinicalTrials.gov Identifier: NCT00200707
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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 3 and 12 months' follow-up.

Condition or disease Intervention/treatment Phase
Acute and Severe Myocardial Infarction Procedure: Intracoronary injection of autologous bone marrow mononuclear cells Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
Study Start Date : December 2004
Primary Completion Date : January 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Experimental: The treatment group
Intracoronary Injection of Autologous Bone Marrow Mononuclear C
Procedure: Intracoronary injection of autologous bone marrow mononuclear cells
No Intervention: the control group



Primary Outcome Measures :
  1. Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) [ Time Frame: after 3 months and 1 year of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women between 18-75 years.
  • Acute myocardial infarction
  • Absence of viability in the infarcted zone and LVEF <45%.

Exclusion Criteria:

  • History of prior myocardial infarction
  • Significant stenosis in another coronary territory than the acutely treated vessel

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): NCT00200707


Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Patricia LEMARCHAND, MD Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00200707     History of Changes
Other Study ID Numbers: BRD/03/2-B
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014

Keywords provided by Nantes University Hospital:
Cell therapy
bone marrow mononuclear cells
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases