NCT01267331

Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery

A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.

Detailed description

Severe ischemic heart disease remains a clinical challenge; many patients have undergone surgical myocardial revascularization procedures, but still remain symptomatic despite optimal medical therapy. Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for surgical treatment in patients with severe, chronic ischemic heart disease. This research study is being performed to find out more information about the safety, feasibility, and efficacy of direct intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG). The heart function evaluations will be performed by electrocardiogram, echocardiogram, and cMRI at baseline and during 6 months follow-up. The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), global and cardiovascular mortality, and major adverse cardiac events after undergoing coronary artery bypass surgery.

Conditions

• Old Myocardial Infarction
• Chronic Myocardial Ischemia
• Left Ventricular Dysfunction

Interventions

Type	Name	Description
PROCEDURE	bone marrow mononuclear cells injection	Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
PROCEDURE	placebo intramyocardial injection	Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2010-12-28
• Last updated: 2011-01-12

Locations

1 site across 1 country: China