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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02565459 |
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Date of registration:
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24/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MSC and Kidney Transplant Tolerance (Phase A)
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Scientific title:
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Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A) |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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22 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02565459 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Italy
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Contacts
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Name:
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Giovanni Rota, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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A.O. Ospedale Papa Giovanni XXIII |
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Name:
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Piero Ruggenenti, MD |
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Address:
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Telephone:
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0039 035 2674037 |
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Email:
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pruggenenti@hpg23.it |
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Affiliation:
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Name:
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Norberto Perico, MD |
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Address:
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Telephone:
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0039 035 45351 |
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Email:
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norberto.perico@marionegri.it |
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Affiliation:
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Name:
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Federica Casiraghi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Di Ricerche Farmacologiche Mario Negri |
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Name:
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Norberto Perico, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Di Ricerche Farmacologiche Mario Negri |
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Name:
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Martino Introna, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Laboratorio G. Lanzani, Bergamo, Italy |
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Name:
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Alessandro Rambaldi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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A.O. Ospedale Papa Giovanni XXIII |
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Name:
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Giuseppe Remuzzi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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A.O. Ospedale Papa Giovanni XXIII |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First single kidney transplant;
- Capable of understanding the purpose and risk of the study;
- Written informed consent.
Exclusion Criteria:
- PRA >10%;
- Specific contraindication to MSC infusion;
- Any clinical relevant condition that might affect study participation and/or study
results;
- Childbearing potential without effective contraception;
- Pregnant women and nursing mothers;
- Unwillingness or inability to follow study protocol in the investigator's opinion.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Renal Failure
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Intervention(s)
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Biological: Mesenchymal Stromal Cells
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Primary Outcome(s)
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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.]
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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.]
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T-cell function in mixed lymphocyte reaction.
[Time Frame: Changes from baseline at 6 and 12 months after transplant.]
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Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR
[Time Frame: Changes from baseline at 6 and 12 months after transplant.]
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Number of adverse events
[Time Frame: Changes from baseline through study completion, up to 12 months after transplant.]
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Secondary ID(s)
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2015-002186-27
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Third-party MSC-Tx tolerance A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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