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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
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 16, 2007
Last Updated
November 16, 2007
Sponsor
University Hospitals, Leicester
Collaborators
British Heart Foundation
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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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