Mesenchymal Stromal Cells in Kidney Transplant Recipients
NCT02012153 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2023-06-01
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.
Conditions
- Kidney Transplant Rejection
Interventions
- BIOLOGICAL
-
Mesenchymal Stromal Cells
Sponsors & Collaborators
-
A.O. Ospedale Papa Giovanni XXIII
collaborator OTHER -
Mario Negri Institute for Pharmacological Research
lead OTHER
Principal Investigators
-
Giuseppe Remuzzi, MD · A.O. Ospedale Papa Giovanni XXIII
-
Norberto Perico, MD · Istituto Di Ricerche Farmacologiche Mario Negri
-
Giovanni Rota, MD · A.O. Ospedale Papa Giovanni XXIII
-
Federica Casiraghi · Istituto Di Ricerche Farmacologiche Mario Negri
-
Martino Introna, MD · Laboratorio G. Lanzani, Bergamo, Italy
-
Alessandro Rambaldi, MD · A.O. Ospedale Papa Giovanni XXIII
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-04
- Primary Completion
- 2023-05-29
- Completion
- 2023-05-29
Countries
- Italy
Study Locations
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