Kidney Transplant Rejection
Conditions
Keywords
Mesenchymal stromal cells, Kidney transplantation, Tolerance
Brief summary
The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. 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.
Interventions
BIOLOGICALMesenchymal Stromal Cells
Sponsors
A.O. Ospedale Papa Giovanni XXIII
Mario Negri Institute for Pharmacological Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients; * Aged 18 or older; * Living-donor (related and unrelated, spouse/husband) kidney transplant recipients; * Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches); * First kidney transplant; * Capable of understanding the purpose and risk of the study; * Written informed consent.
Exclusion criteria
* MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis; * Specific contraindication to MSC infusion; * Any clinical relevant condition that might affect study participation and/or study results; * Pregnant women and nursing mothers; * Unwillingness or inability to follow study protocol in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis). | Changes from baseline at 6 and 12 months after transplant. | — |
| T-cell function by ELISPOT assay in mixed lymphocyte reaction. | Changes from baseline at 6 and 12 months after transplant. | — |
| Number of adverse events. | Changes from baseline up to 48 months. | At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded. |
| Circulating regulatory T cell count. | 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. | — |
Countries
Italy
Outcome results
None listed