drugset / Trial / NCT02260375
MSC Therapy in Liver Transplantation
Phase 1
Unknown
20 enrolled
Monia Lorini
Mario Negri Institute for Pharmacological Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.
Timeline
- Start
- 2014-10
- Primary completion
- 2024-10
- Completion
- 2025-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | mesenchymal stem cells | Cell therapy | 2e+06 cells/kg | Intravenous |