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

Myocardial Infarct Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560742
• Other study ID #: PG04050
• Secondary ID: UHL ref: 7638
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2007
• Last updated: November 16, 2007
• Start date: November 2002
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Cells
• Myocardial Infarct
• Myocardial Infarction

Intervention

Procedure:
• Control
Coronary artery bypass grafting without bone marrow cells injection
• Intramuscular administration of bone marrow cells
Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
• Intracoronary administration of bone marrow cells
Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

Locations

Country	Name	City	State
United Kingdom	University Hospitals Leicester	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contractile function of treated scar areas		6 months
Secondary	Global left ventricular functions		6 months