MSC and Kidney Transplant Tolerance (Phase A)
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|ClinicalTrials.gov Identifier: NCT02565459|
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : April 6, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Failure||Biological: Mesenchymal Stromal Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Mesenchymal Stromal Cells (MSC)
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.
|Biological: Mesenchymal Stromal Cells|
|No Intervention: No intervention|
- Number of adverse events [ Time Frame: Changes from baseline through study completion, up to 12 months after transplant. ]At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
- Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis) [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ]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.
- Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565459
|Contact: Norberto Perico, MD||0039 035 firstname.lastname@example.org|
|U.O. Nefrologia e Dialisi||Recruiting|
|Bergamo, Italy, 24127|
|Contact: Piero Ruggenenti, MD 0039 035 2674037 email@example.com|
|Sub-Investigator: Eliana Gotti, MD|
|Study Chair:||Giuseppe Remuzzi, MD||A.O. Ospedale Papa Giovanni XXIII|
|Study Director:||Norberto Perico, MD||Istituto Di Ricerche Farmacologiche Mario Negri|
|Principal Investigator:||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|