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临床试验/NCT07005687
NCT07005687尚未招募不适用

Using MSCs for Chronic Active Antibody Mediated Rejection

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 10 人开始时间: 2027年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
主要终点
progression of chronicity index

研究概览

简要总结

Mesenchymal stem cell (MSCs) therapy has already been studied in kidney transplant recipients (KTRs), and the available data showed that it is safe and well tolerated. The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR received treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and were followed for up to 12 months. The primary endpoints were safety by assessment of adverse events. Secondary endpoints included assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts. A total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. We found that AMR did not improve in any of the patients after treatment with MSCs. In addition, serious adverse events were observed in one case when autologous MSCs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.

详细描述

The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR will receive treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and will be followed for up to 12 months. The primary endpoints are safety by adverse events. Secondary endpoints include assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • chronic active antibody mediated rejection in kidney transplanted recipients

排除标准

  • 未提供

研究组 & 干预措施

MSCs Derived

Other

干预措施: Stem Cells (Other)

结局指标

主要结局

progression of chronicity index

时间窗: one year after administration

Number of participants with treatment-related adverse events as assessed by kidney biopsy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nooshin dalili

MD

Shahid Beheshti University of Medical Sciences

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