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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003221-29 | EudraCT Number |
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Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center
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| Name | Class |
|---|---|
| A.O. Ospedale Papa Giovanni XXIII | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stromal Cells | Experimental | A single intravenous infusion of ex-vivo expanded autologous MSCs will be performed in patients in addition to the living-donor kidney transplantation. 2x10 elevated to sxth power MSCs per kilogram body weight previously isolated from the same recipient will be infused intravenously the day before the kidney transplant procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stromal Cells | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis). | Changes from baseline at 6 and 12 months after transplant. | |
| T-cell function by ELISPOT assay in mixed lymphocyte reaction. | Changes from baseline at 6 and 12 months after transplant. | |
| Number of adverse events. | At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded. | Changes from baseline up to 48 months. |
| Circulating regulatory T cell count. | Changes from baseline at 6 and 12 months after transplant. | |
| Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR. | Changes from baseline at 6 and 12 months after transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Remuzzi, MD | A.O. Ospedale Papa Giovanni XXIII | Study Chair |
| Norberto Perico, MD | Istituto Di Ricerche Farmacologiche Mario Negri | Study Director |
| Giovanni Rota, MD | A.O. Ospedale Papa Giovanni XXIII | Principal Investigator |
| Federica Casiraghi | Istituto Di Ricerche Farmacologiche Mario Negri | Principal Investigator |
| Martino Introna, MD | Laboratorio G. Lanzani, Bergamo, Italy | Principal Investigator |
| Alessandro Rambaldi, MD | A.O. Ospedale Papa Giovanni XXIII | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Nefrologia e Dialisi | Bergamo | 24127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29963053 | Derived | Perico N, Casiraghi F, Todeschini M, Cortinovis M, Gotti E, Portalupi V, Mister M, Gaspari F, Villa A, Fiori S, Introna M, Longhi E, Remuzzi G. Long-Term Clinical and Immunological Profile of Kidney Transplant Patients Given Mesenchymal Stromal Cell Immunotherapy. Front Immunol. 2018 Jun 14;9:1359. doi: 10.3389/fimmu.2018.01359. eCollection 2018. |
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