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Trial/study phase/outcome | Primary endpoint | Secondary endpoints |
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Induction therapy with autologous MSCs in living-related kidney transplants; phase II Lower incidence of BPAR, decreased risk of infections compared to IL-2RB induction [18]. | (i) BPAR (ii) Renal function (MDRD) | (i) Patient and graft survival (ii) Adverse events |
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Autologous MSCs to induce tolerance in living-donor kidney transplant recipients; phase I Recruiting. ClinicalTrials.gov identifier: NCT02012153 | Adverse events | (i) T cell counts (flow cytometry) (ii) Functional assays (ELISPOT in MLR) (iii) Regulatory T cell counts (flow cytometry) (iv) Urinary Foxp3 mRNA expression (qPCR) |
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Autologous MSCs under Basiliximab/low-dose RATG to induce renal transplant tolerance; phase I MSC administered at day 7 induced graft dysfunction. Not observed when MSCs were given day 1. Expansion of regulatory T cells and control of memory CD8+ T cell function [12, 13]. | Safety related to MSC infusion | (i) Immunophenotyping T cells (Flow cytometry) (ii) Functional assays (ELISPOT for IFN-γ and Granzyme-B, cell-mediated lympholysis, HLA specific antibodies) (iii) Histology and Immunohistochemistry (graft infiltrating cells, MSC localization, complement deposition) |
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Autologous MSCs and subclinical rejection; phase I Feasible and safe. MSCs had immunosuppressive effects (3 patients suffered from opportunistic infections, 5 patients displayed downregulation of MLR), resolution of tubulitis [14]. | (i) Adverse events (ii) Number of expanded MSCs (iii) Number of passages required | (i) Late acute rejections (ii) Histology (iii) Immunophenotyping T cells (flow cytometry) (iv) Functional assays (MLR, cytokines, HLA specific antibodies) |
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Autologous MSCs in combination with Everolimus to preserve renal structure and function in renal transplant recipients; phase II Recruiting [11]. ClinicalTrials.gov identifier: NCT02057965 | Histology (fibrosis by Sirius red) | (i) Adverse events including (opportunistic) infections (ii) BPAR (iii) Graft and patient survival (iv) Renal function (iohexol, MDRD) (v) Immune monitoring (One study) (vi) Cardiovascular endpoints |
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Autologous MSC transplantation in the treatment of chronic allograft nephropathy; phases I-II Status unknown. ClinicalTrials.gov identifier: NCT00659620 | Renal function (Cr and CrCl) | (i) Patient and graft survival (ii) Proportion of renal biopsies after 12 months (ii) Adverse events including (opportunistic) infections |
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Safety and efficacy of autologous MSCs transplantation in patients undergoing living-donor kidney transplantation; phase I Safe and feasible. Expansion of regulatory T cell population and reduced T cell proliferation [17]. | Adverse events | (i) Immunophenotyping T cells (flow cytometry) (ii) Functional assays (proliferation assay) (iii) Renal function (Cr) |
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