Chronic Renal Failure Clinical Trial
Official title:
Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
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).
Status | Recruiting |
Enrollment | 22 |
Est. completion date | December 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | U.O. Nefrologia e Dialisi | Bergamo |
Lead Sponsor | Collaborator |
---|---|
Monia Lorini | Mario Negri Institute for Pharmacological Research |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | ||
Primary | 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. | ||
Primary | 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. | |
Primary | Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR | Changes from baseline at 6 and 12 months after transplant. |
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