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

规范的药理免疫抑制可以实现肝移植和患者的合理存活。然而，现有的治疗方案也可能带来不良的、临床上显著的副作用，对患者健康产生负面影响。因此，我们希望实施一项由研究人员发起的人类临床I期研究，以研究使用间充质干细胞作为标准药物免疫抑制的辅助手段进行细胞免疫调节治疗。我们建议的研究是由首席研究员(PI)和他的团队在过去两年里准备的。根据保罗-埃利希研究所(PEI)和雷根斯堡大学伦理委员会(EC)提供的科学建议和指导，这项试验被设计为一项可行性和安全性研究，建立在3+3剂量递增计划的基础上。这项研究人员发起的试验将对一家私营公司生产的细胞产品进行严格评估。国际保护协会保留完全赞助商的权利和义务，包括出版权。当地的设施和公用事业已经过广泛的审查，适合这项试验。专门创建了一个定制的质量管理体系来支持研究的程序方面。MSOT-I随后获得了欧盟委员会和PEI的批准，并已准备好启动。

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.