NCT01727063

Cell Therapy in Severe Chronic Ischemic Heart Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Ministry of Health, Brazil · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization. This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

Detailed description

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery. During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Conditions

• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Angina Pectoris

Interventions

Type	Name	Description
PROCEDURE	Cell Therapy	Intramyocardial injection of autologous bone marrow-derived cells

Timeline

• Start date: 2006-01-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2012-11-15
• Last updated: 2019-08-30

Locations

1 site across 1 country: Brazil