Safety and feasibility of multipotent adult progenitor cells for immunomodulation therapy after liver transplantation: A phase I study

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Standard-of-care pharmacological immunosuppression can achieve reasonable survival ofliver grafts and patients. However, existing therapeutic regimes can also impart undesirable,clinically significant side-effects that impact negatively on patient health. We therefore wantto implement an investigator-initiated, clinical phase I study in humans to study cellularimmunomodulation therapy with mesenchymal stem cells as an adjunct to standardpharmacological immunosuppression.Our proposed study has been prepared by the Principal Investigator (PI) and his team overthe last two years. This trial has been designed as a feasibility and safety study built on a3+3 dose escalation scheme following scientific advice and guidance provided by the Paul-Ehrlich-Institute (PEI) and by the Ethics Committee (EC) of the University of Regensburg.This investigator initiated trial will critically assess a cell product produced by a privatecompany. The PI retains full sponsor’s rights and duties, including publication rights. Thelocal site facilities and utilities have been extensively reviewed and are suitable for this trial.A bespoke quality management system was created specifically to support the proceduralaspects of the study. MiSOT-I was subsequently approved by the EC and PEI and is readyfor initiation.