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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001531-37 | 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 allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.
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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 MSC (from healthy donors) will be performed in patients assigned to the MSC procedure in addition to the liver transplantation. |
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| No treatment. | 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 up to 120 month. |
| Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes | At 12 and 60 month. | |
| Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis) | Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month. | |
| T-cell function in mixed lymphocyte reaction | Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month. |
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Inclusion Criteria:
For this study, the following inclusion criteria should be fulfilled before starting withdrawal of drugs after 1 year post-transplant:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Remuzzi, MD | Contact | 0039 0352674037 | gremuzzi@hpg23.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Remuzzi, MD | A.O. Ospedale Papa Giovanni XXIII | Study Chair |
| Norberto Perico, MD | IRCCS-Istituto di Ricerche Farmacologiche M. Negri | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S.C Nefrologia e Dialisi | Recruiting | Bergamo | 24127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33370477 | Derived | Casiraghi F, Perico N, Podesta MA, Todeschini M, Zambelli M, Colledan M, Camagni S, Fagiuoli S, Pinna AD, Cescon M, Bertuzzo V, Maroni L, Introna M, Capelli C, Golay JT, Buzzi M, Mister M, Ordonez PYR, Breno M, Mele C, Villa A, Remuzzi G; MSC-LIVER Study Group. Third-party bone marrow-derived mesenchymal stromal cell infusion before liver transplantation: A randomized controlled trial. Am J Transplant. 2021 Aug;21(8):2795-2809. doi: 10.1111/ajt.16468. Epub 2021 Feb 22. |
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| Michele Colledan, MD |
| A.O. Ospedale Papa Giovanni XXIII |
| Principal Investigator |
| Stefano Fagiuoli, MD | A.O. Ospedale Papa Giovanni XXIII | Principal Investigator |
| Martino Introna, MD | Laboratorio G.Lanzani, Bergamo, Italy | Principal Investigator |
| Alessandro Rambaldi, MD | A.O. Ospedale Papa Giovanni XXIII | Principal Investigator |
| Antonio Pinna, MD | Policlinico S. Orsola Bologna, Italy | Principal Investigator |
| Claudio Velati, MD | Policlinico S. Orsola Bologna, Italy | Principal Investigator |
| USC Chirurgia Generale III | Recruiting | Bergamo | 24127 | Italy |
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| USC Ematologia | Recruiting | Bergamo | 24127 | Italy |
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| USC Gastroenterologia | Recruiting | Bergamo | 24127 | Italy |
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| Servizio di Immunoematologia e Medicina Trasfusionale | Recruiting | Bologna | 40138 | Italy |
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| Unità Chirurgia Generale e Trapianti | Recruiting | Bologna | 40138 | Italy |
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