Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium

NCT ID: NCT00560742

Last Updated: 2007-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarct Bone Marrow Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Coronary artery bypass grafting without bone marrow cells injection

Intramuscular

Group Type EXPERIMENTAL

Intramuscular administration of bone marrow cells

Intervention Type PROCEDURE

Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar

Intracoronary

Group Type EXPERIMENTAL

Intracoronary administration of bone marrow cells

Intervention Type PROCEDURE

Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

Interventions

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Control

Coronary artery bypass grafting without bone marrow cells injection

Intervention Type PROCEDURE

Intramuscular administration of bone marrow cells

Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar

Intervention Type PROCEDURE

Intracoronary administration of bone marrow cells

Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role lead

Principal Investigators

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Manuel GaliƱanes, MD PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Locations

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University Hospitals Leicester

Leicester, Leicestershire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UHL ref: 7638

Identifier Type: -

Identifier Source: secondary_id

PG04050

Identifier Type: -

Identifier Source: org_study_id