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OpenTrials
Completed

NCT Number: NCT00560742

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

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.

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Key information

Conditions

Myocardial Infarct Bone Marrow Cells Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

Coronary artery bypass grafting without bone marrow cells injection

Intramuscular administration of bone marrow cells

Procedure

Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar

Intracoronary administration of bone marrow cells

Procedure

Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar

Primary outcomes

  1. Contractile function of treated scar areas

    Time frame: 6 months

Secondary outcomes

  1. Global left ventricular functions

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • British Heart Foundation

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Nov 20, 2007
Registry last updated
Nov 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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