Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery
Recruitment status was: Recruiting
|Old Myocardial Infarction Chronic Myocardial Ischemia Left Ventricular Dysfunction||Procedure: bone marrow mononuclear cells injection Procedure: placebo intramyocardial injection||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||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|
- major adverse cardiac events [ Time Frame: 6 months ]Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery
- left ventricular function [ Time Frame: 6 months ]Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: stem cells injection
Direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG
Procedure: bone marrow mononuclear cells injection
Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
Other Name: autologous bone marrow mononuclear cells
Placebo Comparator: palcebo intramyocardial injection
Direct intramyocardial injection of placebo containing saline and 5% human serum albumin 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.
Other Name: palcebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267331
|Contact: Changqing Gao, MDfirstname.lastname@example.org|
|Contact: Lin Zhang, MDemail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Principal Investigator: Wang Rong, MD|
|Principal Investigator: Zhang Lin, MD|
|Study Chair:||Gao Changqing, MD||Chinese PLA General Hospital|