NCT02565459

MSC and Kidney Transplant Tolerance (Phase A)

Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Monia Lorini · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. 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. The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).

Conditions

• Chronic Renal Failure

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal Stromal Cells

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2015-10-01
• Last updated: 2018-04-06

Locations

1 site across 1 country: Italy