Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
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|ClinicalTrials.gov Identifier: NCT00395811|
Recruitment Status : Unknown
Verified October 2008 by China National Center for Cardiovascular Diseases.
Recruitment status was: Active, not recruiting
First Posted : November 3, 2006
Last Update Posted : October 29, 2008
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with myocardial infarction.
50 patients with stable left ventricle function will - with six months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories and Coronary Artery Bypass Graft (CABG).
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Myocardial Infarction||Procedure: Bone Marrow Stem Cell Therapy combined CABG||Phase 1 Phase 2|
This research study is being performed to find out more information about the safety and efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial infarction, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The researchers are trying to find out if the transplantation of these stem cell can make a change in the functioning of these areas of the heart muscle.
Patients between 18 and 70 years of age who received autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
These patients receive autologous bone marrow cells transplantation intracoronary undergoing Coronary Artery Bypass Graft. The objective evaluations will be performed at baseline and during 6 months follow-up.
Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
- MRI evaluates function of the heart chambers the beating motion of the muscle.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||June 2009|
- Procedure: Bone Marrow Stem Cell Therapy combined CABG
Bone Marrow Stem Cell inject into myocardium
- Changes in left ventricular ejection fraction from baseline to 6 months' follow-up [ Time Frame: 3 year ]
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): NCT00395811
|Fuwai cardiovascular disease hospital|
|Beijing, China, 100037|
|Study Director:||Hu shengshou||National center for cardiovascular disease ,china|