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

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00560742
First received: November 16, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 2

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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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

No publications provided

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

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014