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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002186-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Mario Negri Institute for Pharmacological Research | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stromal Cells (MSC) | Experimental | A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation. |
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| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stromal Cells | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded. | Changes from baseline through study completion, up to 12 months after transplant. |
| Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis) | Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant. | |
| Circulating regulatory T cell count. | Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant. | |
| T-cell function in mixed lymphocyte reaction. | IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction. | 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Norberto Perico, MD | Contact | 0039 035 45351 | norberto.perico@marionegri.it |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Nefrologia e Dialisi | Recruiting | Bergamo | 24127 | Italy |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |