Mesenchymal Stromal Cells in Kidney Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mesenchymal Stromal Cells A single intravenous infusion of ex-vivo expanded autologous MSCs will be performed in patients in addition to the living-donor kidney transplantation. 2x10 elevated to sxth power MSCs per kilogram body weight previously isolated from the same recipient will be infused intravenously the day before the kidney transplant procedure. |
Biological: Mesenchymal Stromal Cells
|
Outcome Measures
Primary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female patients;
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Aged 18 or older;
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Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
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Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
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First kidney transplant;
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Capable of understanding the purpose and risk of the study;
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Written informed consent.
Exclusion Criteria:
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MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
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Specific contraindication to MSC infusion;
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Any clinical relevant condition that might affect study participation and/or study results;
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Pregnant women and nursing mothers;
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Unwillingness or inability to follow study protocol in the investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U.O. Nefrologia e Dialisi | Bergamo | Italy | 24127 |
Sponsors and Collaborators
- Mario Negri Institute for Pharmacological Research
- A.O. Ospedale Papa Giovanni XXIII
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSC-Tx tolerance
- 2013-003221-29