Abstract
Regenerative medicine has rapidly evolved, due to progress in cell and molecular biology allowing the isolation, characterization, expansion, and engineering of cells as therapeutic tools. Despite past limited success in the clinical translation of several promising preclinical results, this novel field is now entering a phase of renewed confidence and productivity, marked by the commercialization of the first cell therapy products. Ongoing issues in the field include the use of pluripotent vs. somatic and of allogenic vs. autologous stem cells. Moreover, the recognition that several of the observed beneficial effects of cell therapy are not due to integration of the transplanted cells, but rather to paracrine signals released by the exogenous cells, is generating new therapeutic perspectives in the field. Somatic stem cells are outperforming embryonic and induced pluripotent stem cells in clinical applications, mainly because of their more favorable safety profile. Presently, both autologous and allogeneic somatic stem cells seem to be equally safe and effective under several different conditions. Recognition that a number of therapeutic effects of transplanted cells are mediated by paracrine signals, and that such signals can be found in extracellular vesicles isolated from culture media, opens novel therapeutic perspectives in the field of regenerative medicine.
Highlights
Regenerative medicine is a young discipline that has rapidly evolved during the last twenty years due to the remarkable progress of cell and molecular biology, which has paved the way to the use of living cells as therapeutic tools for a variety of diseases
The recognition that several of the observed beneficial effects of cell therapy are not due to integration of the transplanted cells, but rather to paracrine signals released by the exogenous cells, is generating new therapeutic perspectives in the field
Recognition that a number of therapeutic effects of transplanted cells are mediated by paracrine signals, and that such signals can be found in extracellular vesicles isolated from culture media, opens novel therapeutic perspectives in the field of regenerative medicine
Summary
Regenerative medicine is a young discipline that has rapidly evolved during the last twenty years due to the remarkable progress of cell and molecular biology, which has paved the way to the use of living cells ( stem cells) as therapeutic tools for a variety of diseases. Results of a clinical study on intravenous (iv) MSC administration as a therapeutic approach for chronic heart failure have been presented at the European Society of Cardiology Congress 2016 [28] This phase IIa single-blind, placebo-controlled crossover clinical trial evaluated iv infusion of allogeneic ischemia-tolerant mesenchymal stem cells (itMSCs) in 22 patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction of less than 40%. This study suggests that intravenously administered itMSCs suppress inflammation, a critical pathogenic element in the progression of heart failure, as there was a statistically significant reduction in natural killer (NK) cells, which correlated with the improvement in left ventricular ejection fraction In another recent report [29], 18 patients with stable, chronic stroke were enrolled in a two-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical intra-cranial transplantation of modified bone marrow-derived MSCs (SB623). Understanding the delicate balance between beneficial and potentially harmful secreted factors is a key issue to successfully exploit the immune modulatory effects of MSCs [50]
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