Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01267331|
Recruitment Status : Unknown
Verified December 2010 by Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : December 28, 2010
Last Update Posted : January 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Old Myocardial Infarction Chronic Myocardial Ischemia Left Ventricular Dysfunction||Procedure: bone marrow mononuclear cells injection Procedure: placebo intramyocardial injection||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|