Long-term results of intramyocardial CD133+ bone marrow stem cell therapy for myocardial ischemia: experience with stem cell register

Abstract

Standardization of stem cell therapy requires application of appropriate methods to evaluate safety and efficacy, including long-term pharmacovigilance. To accomplish this objective, a long-term registry program was installed in the Regeneration and Translation Center for cardiac stem cell therapy in Rostock, Germany 14 years ago. The registry program in RTC contains parameters for the evaluation of functional outcomes and safety including major adverse cardiovascular and cerebral events (MACCEs). The register follows 223 patients with a total of 1152 patient years, who are observed yearly lifelong after stem cell application or as a control groups. The present study was done in 96 patients (n=73 cell therapy, n=23 control group) with coronary arterial disease and heart failure, treated with coronary artery bypass operation with or without stem cells injections. The analysis revealed, that owing to yearly MACCE registrations, register allow that late probable complications are carefully followed as well as unexpected complication reported, which is required to ensure patient's safety as the main aspect of Good Clinical Practice. Nevertheless, the registry by itself cannot substitute randomized clinical trials, as patient's cohort is heterogeneous. However, registry data can be used for long term efficiency and safety evaluation in standardized patient groups. Furthermore, registry program could help to improve patient selection revealing predictors of good response and define patients who did not respond to the stem cell therapy. It is expedient to establish an obligatory common registry program for all centers, carrying stem cell studies.

CD133+ Stem Cell Therapy Effects on Myocardial Regeneration Through Increased Vascular Endothelial Growth Factor Correlate with Cardiac Magnetic Resonance Imaging Results in Coronary Artery Bypass Graft Surgery Patients with Low Ejection Fraction

“…Although the improvement of myocardial perfusion and ventricular dimensions was not significant in the treatment group, VEGF levels are expected to continue the improvement of perfusion, cardiomyogenesis, and extracellular matrix, leading to improvement of cardiac function. These factors increase the quality of life of the patients [Nesteruk 2016].…”