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

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ClinicalTrials.gov Identifier: NCT00560742
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : November 20, 2007
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2002
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Contractile function of treated scar areas [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Global left ventricular functions [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00560742     History of Changes
Other Study ID Numbers: PG04050
UHL ref: 7638
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

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