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

NHS Trust

Status and phase: Completed; Phase 2

Conditions: Myocardial Infarct; Bone Marrow Cells

Treatments: Procedure: Intramuscular administration of bone marrow cells; Procedure: Control; Procedure: Intracoronary administration of bone marrow cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00560742

UHL ref: 7638

PG04050

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups

Control

Active Comparator group

Treatment:

Procedure: Control

Intramuscular

Experimental group

Treatment:

Procedure: Intramuscular administration of bone marrow cells

Intracoronary

Experimental group

Treatment:

Procedure: Intracoronary administration of bone marrow cells