Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities

Abstract

Mesenchymal stromal cells (MSCs) have been the subject of clinical trials for more than a generation, and the outcomes of advanced clinical trials have fallen short of expectations raised by encouraging pre-clinical animal data in a wide array of disease models. In this Perspective, important biological and pharmacological disparities in pre-clinical research and human translational studies are highlighted, and analyses of clinical trial failures and recent successes provide a rational pathway to MSC regulatory approval and deployment for disorders with unmet medical needs.

Keywords: Crohn’s disease; FDA; biomarkers; clinical trials; efferocytosis; graft versus host disease; immune compatibility; mesenchymal stromal cells; thawing.