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

Phase 2

Completed

• Conditions: Bone Marrow Cells; Myocardial Infarct
• Interventions: Procedure: Control; Procedure: Intramuscular administration of bone marrow cells; Procedure: Intracoronary administration of bone marrow cells

• Registration Number: NCT00560742
• Lead Sponsor: University Hospitals, Leicester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2007-07
• Status Verified: 2007-11
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Last Update Submitted: 2007-11-16
• Study First Posted: 2007-11-20
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Intramuscular	Intramuscular administration of bone marrow cells	-
Intracoronary	Intracoronary administration of bone marrow cells	-

Primary Outcome Measures

Name	Time	Method
Contractile function of treated scar areas	6 months

Secondary Outcome Measures

Name	Time	Method
Global left ventricular functions	6 months

Trial Locations

Locations (1)

University Hospitals Leicester; 🇬🇧 Leicester, Leicestershire, United Kingdom