drugset / Trial / NCT02012153
Mesenchymal Stromal Cells in Kidney Transplant Recipients
Phase 1
Terminated
3 enrolled
Mario Negri Institute for Pharmacological Research
A.O. Ospedale Papa Giovanni XXIII · collab
NaSingle-groupOpen-labelTreatment
Summary
The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.
Timeline
- Start
- 2013-12-04
- Primary completion
- 2023-05-29
- Completion
- 2023-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 2e+06 cells/kg | Intravenous |