Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium
Primary Purpose
Myocardial Infarct, Bone Marrow Cells
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Control
Intramuscular administration of bone marrow cells
Intracoronary administration of bone marrow cells
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarct
Eligibility Criteria
Inclusion Criteria:
- patients undergoing elective CABG
- chronic irreversible myocardial scar
- coronary vessel supplying the scar must be amenable to bypass grafting
Exclusion Criteria:
- significant valvular heart diseases
- major organ failures, eg. heart, liver, renal etc
- pre-existing bone marrow conditions
Sites / Locations
- University Hospitals Leicester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Intramuscular
Intracoronary
Arm Description
Outcomes
Primary Outcome Measures
Contractile function of treated scar areas
Secondary Outcome Measures
Global left ventricular functions
Full Information
NCT ID
NCT00560742
First Posted
November 16, 2007
Last Updated
November 16, 2007
Sponsor
University Hospitals, Leicester
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00560742
Brief Title
Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium
Official Title
Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals, Leicester
Collaborators
British Heart Foundation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarct, Bone Marrow Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Title
Intramuscular
Arm Type
Experimental
Arm Title
Intracoronary
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Coronary artery bypass grafting without bone marrow cells injection
Intervention Type
Procedure
Intervention Name(s)
Intramuscular administration of bone marrow cells
Intervention Description
Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
Intervention Type
Procedure
Intervention Name(s)
Intracoronary administration of bone marrow cells
Intervention Description
Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar
Primary Outcome Measure Information:
Title
Contractile function of treated scar areas
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Global left ventricular functions
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing elective CABG
chronic irreversible myocardial scar
coronary vessel supplying the scar must be amenable to bypass grafting
Exclusion Criteria:
significant valvular heart diseases
major organ failures, eg. heart, liver, renal etc
pre-existing bone marrow conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Galiñanes, MD PhD FRCS
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leicester
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium
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