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

November 16, 2007 updated by: University Hospitals, Leicester

Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
        • University Hospitals Leicester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Procedure: Control
Coronary artery bypass grafting without bone marrow cells injection
Experimental: Intramuscular
Procedure: Intramuscular administration of bone marrow cells
Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
Experimental: Intracoronary
Procedure: Intracoronary administration of bone marrow cells
Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contractile function of treated scar areas
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Global left ventricular functions
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: Manuel Galiñanes, MD PhD FRCS, University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 16, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG04050
  • UHL ref: 7638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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