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

This study has been completed.

Sponsors and Collaborators:	University Hospitals, Leicester British Heart Foundation
Information provided by:	University Hospitals, Leicester
ClinicalTrials.gov Identifier:	NCT00560742

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarct Bone Marrow Cells	Procedure: Control Procedure: Intramuscular administration of bone marrow cells Procedure: Intracoronary administration of bone marrow cells	Phase II

MedlinePlus related topics: Heart Attack Scars

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:

Contractile function of treated scar areas [ Time Frame: 6 months ]

Secondary Outcome Measures:

Global left ventricular functions [ Time Frame: 6 months ]

Enrollment:	63
Study Start Date:	November 2002
Study Completion Date:	July 2007

Arms	Assigned Interventions
Control: Active Comparator	Procedure: Control Coronary artery bypass grafting without bone marrow cells injection
Intramuscular: Experimental	Procedure: Intramuscular administration of bone marrow cells Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
Intracoronary: Experimental	Procedure: Intracoronary administration of bone marrow cells Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560742

Locations

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

Sponsors and Collaborators

University Hospitals, Leicester

British Heart Foundation

Investigators

Principal Investigator:

Manuel Galiñanes, MD PhD FRCS

University Hospitals, Leicester

More Information

Study ID Numbers:	PG04050, UHL ref: 7638
Study First Received:	November 16, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00560742
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Infarction
Myocardial Infarction
Cicatrix

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009