Stem Cell Implantation in Patients Undergoing CABG
The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed.
The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.
|Ischemic Cardiomyopathy Coronary Artery Disease||Device: Autologous CD133+ Bone Marrow Stem Cells Other: Carrier Solution||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Stem Cell Implantation in Patients Undergoing CABG|
- Freedom from a Major Adverse Cardiac Event (MACE) [ Time Frame: Six months ]Defined as cardiac death, myocardial infarction (CK/CK-MB over 5 times the upper limit of normal), repeat coronary bypass grafting, or a repeat percutaneous intervention of bypassed coronary artery.
- Feedom from any major arrhythmias [ Time Frame: Six months ]Defined as sustained ventricular tachycardia or survived sudden death.
- Regional myocardial perfusion and function assessed by comparing paired magnetic resonance scans, ECHOs and SPECT scans obtained prior to CABG and again at 6 months post CABG. [ Time Frame: 6 months ]
- Symptom severity and quality of life at 6 months after CABG surgery. [ Time Frame: 6 months ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Autologous CD133+ Bone Marrow Stem Cells
Intra-myocardial injection of autologous CD133+ cells in suspension.
Device: Autologous CD133+ Bone Marrow Stem Cells
Intra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells
Placebo Comparator: Carrier Solution
Intra-myocardial inception of carrier solution.
Other: Carrier Solution
Intra-myocardial injection of carrier solution
Coronary heart disease (CHD) is the leading cause of death in the U.S. in both men and women and the aging of the population and rising prevalence of diabetes ensure that the number of persons with CHD will continue to increase over the next several decades. Two major factors contributing to adverse outcomes in patients undergoing coronary artery bypass grafting (CABG) surgery are failure to achieve complete revascularization, and residual impairment in left ventricular function.
In the present study, the investigators propose a Phase I randomized double-blind study designed to assess the feasibility and safety of autologous CD133+ cells in patients referred for CABG who have significant regions of viable but non-revascularizable myocardium and/or significant LV systolic dysfunction not likely to improve with conventional coronary revascularization.
Autologous CD133+ bone marrow progenitor cells will be harvested from study subjects at the time of CABG, processed and then injected into patients' myocardium prior to completion of CABG surgery. The test material consists of autologous CD133+ cells. Since intra-myocardial injections per se could stimulate neovascularization, control group patients will receive a placebo injection of carrier solution. Control subjects will thus have an identical procedure to those randomized to autologous CD133+ cell injections.
The three goals of the study are as follows:
- To demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133+ bone marrow cells in adults with chronic ischemic cardiomyopathy associated with impair left ventricular function.
- To assess the effect of autologous CD133+ cell injections on regional myocardial perfusion and function by comparing paired magnet resonance scans obtained prior to CABG and again 6 months post CABG.
- To assess the effect of autologous CD133+ stem cell injections on symptom severity and quality of life at 6 months after CABG surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721902
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Yi-Ping J Woo, M.D.||University of Pennsylvania|