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Published on: September 3, 2020
Autologous CD133 + Cells and Laser Revascularization in patients with severe Ischemic Cardiomyopathy
Ahmed Abdel-Latif1,2, Taha Ahmed1, Steve W Leung1
1Department of Cardiovascular Medicine, Division of Cardiology, University of Kentucky, Lexington, KY, USA.
Insights
This study shows that combining transmyocardial laser revascularization (TMLR) with CD133+ progenitor cell therapy is safe and feasible for chronic ischemic cardiomyopathy patients. The combined therapy demonstrated short-term symptom improvement and reduced ischemia.
Area of Science:
- Cardiovascular Medicine
- Regenerative Medicine
- Interventional Cardiology
Background:
- Chronic ischemic cardiomyopathy (ICM) significantly impacts patient quality of life.
- Limited revascularization options exist for patients with severe multivessel ischemic heart disease.
- Cell-based therapies hold promise for myocardial regeneration.
Purpose of the Study:
- To evaluate the safety and feasibility of combining transmyocardial laser revascularization (TMLR) with autologous CD133+ progenitor cell transplantation.
- To assess the impact of this combination therapy on patients with chronic ICM and no revascularization options.
Main Methods:
- Eight male patients with severe ICM underwent TMLR followed by intramyocardial injection of autologous CD133+ cells.
- CD133+ cells were isolated from bone marrow using a clinical-grade closed system.
- Clinical assessments and myocardial perfusion imaging were performed pre-procedure and at 6 and 12 months post-procedure.
Main Results:
- The combined TMLR and CD133+ cell therapy was feasible and safe, with no major peri-operative complications.
- One patient experienced a cardiac death at 6 months post-procedure.
- Short-term improvements in angina and heart failure symptoms were observed, along with a modest reduction in myocardial ischemia.
Conclusions:
- Combination therapy of TMLR and autologous CD133+ progenitor cells is a feasible and safe approach for selected ICM patients.
- The study supports further investigation in larger Phase 2 randomized clinical trials.
- This approach may offer a new therapeutic option for patients with limited revascularization choices.
Objective:
We tested the hypothesis that targeted TMLR combined with intramyocardial injection of autologous CD 133+ progenitor cells is safe and feasible in patients with chronic ischemic cardiomyopathy (ICM) and no revascularization options.
Methods:
Eight male patients (age 62 ± 2.4 years) with multivessel severe ischemic heart disease and no revascularization options were enrolled. Autologous CD 133 + endothelial progenitor cells were derived and purified from the bone marrow on the day of surgery using the clinical-grade closed CliniMACS system. Using a lateral thoracotomy approach, TMLR was performed, followed by transmyocardial transplantation of purified CD133 + cells (mean number of transplanted cells: 12.5 × 106) in the region surrounding the TMLR sites. These sites were selected based on ischemia on pre-procedure perfusion imaging. We performed clinical and myocardial perfusion imaging pre-procedure and then at 6- and 12-month follow-up.
Results:
No major complications or death occurred during the procedure or during the peri-operative hospital stay. One patient died of cardiac cause 6 months post-procedure. There was a reported short-term improvement in anginal and heart failure symptoms and a modest reduction in the ischemic score as assessed by perfusion imaging.
Conclusions:
Our phase 1 clinical study examining the combination therapy of targeted transmyocardial laser revascularization therapy and autologous CD133 + endothelial progenitor cells in patients with chronic ICM and no revascularization options demonstrates the feasibility and short-term safety of this combined approach and warrants future larger phase 2 randomized clinical studies.
