NCT00560742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 16, 2007

Last Update Submit

November 16, 2007

Conditions

Myocardial InfarctBone Marrow Cells

Outcome Measures

Primary Outcomes (1)

  • Contractile function of treated scar areas

    6 months

Secondary Outcomes (1)

  • Global left ventricular functions

    6 months

Study Arms (3)

Control

ACTIVE COMPARATOR
Procedure: Control

Intramuscular

EXPERIMENTAL
Procedure: Intramuscular administration of bone marrow cells

Intracoronary

EXPERIMENTAL
Procedure: Intracoronary administration of bone marrow cells

Interventions

ControlPROCEDURE

Coronary artery bypass grafting without bone marrow cells injection

Control
Intracoronary administration of bone marrow cellsPROCEDURE

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

Intracoronary
Intramuscular administration of bone marrow cellsPROCEDURE

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

Intramuscular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective CABG
  • chronic irreversible myocardial scar
  • coronary vessel supplying the scar must be amenable to bypass grafting

You may not qualify if:

  • significant valvular heart diseases
  • major organ failures, eg. heart, liver, renal etc
  • pre-existing bone marrow conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Manuel Galiñanes, MD PhD FRCS

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 20, 2007

Study Start

November 1, 2002

Study Completion

July 1, 2007

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

GB(1)