Clinical Trial of Allogeneic Mesenchymal Stem Cell Therapy for Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients Unresponsive to Rituximab and Intravenous Immunoglobulin.
Clinical Trial of Allogeneic Mesenchymal Stem Cell Therapy for Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients Unresponsive to Rituximab and Intravenous Immunoglobulin.
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DOI：
10.1155/2021/6672644
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发表时间：
2021
影响因子：
4.3
通讯作者：
Yang CW
中科院分区：
文献类型：
--
作者：
Ban TH;Lee S;Kim HD;Ko EJ;Kim BM;Kim KW;Chung BH;Yang CW
针对肾移植受者慢性主动抗体介导的排斥反应(CAMR)的生物制剂的临床试验一直令人失望。我们进行了间充质干细胞(MSC)治疗对利妥昔单抗和静脉免疫球蛋白无效的CAMR的KTRs的临床试验。这项研究是第一阶段的临床试验，以确认患者的安全性。纳入2例CAMR患者，对利妥昔单抗和静脉注射免疫球蛋白无效。每例患者均接受4个周期的同种异体骨髓间充质干细胞移植，每隔一周1×106个/kg。我们观察了最后一次MSC输注后6个月的不良事件和肾功能，并分析了从治疗开始到最后一次MSC输注后3个月外周血中免疫调节参数的变化。在研究期间没有发生严重的不良反应。在骨髓间充质干细胞治疗期间，肾功能稳定，但从最后一次骨髓间充质干细胞输注到研究终点(患者1：肌酐水平从3.01 mg/dL到7.81 mg/dL，患者2：2.87 mg/dL到3.91 mg/dL)逐渐下降。在治疗开始到最后一次MSC输注后3个月的外周血样分析中，免疫调节标记物也有类似的趋势。我们的研究表明，在对利妥昔单抗和静脉注射免疫球蛋白无效的CAMR患者中，同种异体MSC治疗后6个月内没有严重的不良事件发生，但需要进一步研究确定MSC治疗CAMR的疗效。
Clinical trials of biologic agents for chronic active antibody-mediated rejection (CAMR) in kidney transplant recipients (KTRs) have been disappointing. We performed a clinical trial of mesenchymal stem cell (MSC) treatment in KTRs with CAMR unresponsive to rituximab and intravenous immunoglobulin. This study was a phase 1 clinical trial to confirm patient safety. Two patients with CAMR unresponsive to rituximab and intravenous immunoglobulin were included. Each patient received allogeneic MSCs for 4 cycles (1 × 106 cells/kg every other week) via the peripheral vein in the distal arm. We observed adverse events and renal function for 6 months after the final MSC infusion and analyzed changes in immunomodulatory parameters in the peripheral blood between the start of treatment and 3 months after the final MSC infusion. There were no serious adverse events during the study period. Renal function was stable during MSC treatment but gradually decreased between the final MSC infusion and the study endpoint (patient 1: creatinine levels ranged from 3.01 mg/dL to 7.81 mg/dL, patient 2: 2.87 mg/dL to 3.91 mg/dL). In peripheral blood sample analysis between the start of treatment and 3 months after the final MSC infusion, there were similar trends for immunomodulatory markers. Our study showed that there were no serious adverse events for six months after allogeneic MSC treatment in KTRs with CAMR refractory to rituximab and intravenous immunoglobulin, but further studies need to define the efficacy of MSC treatment in CAMR.
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影响因子：
7.5
作者：
Chen C;Hou J
通讯作者：
Hou J
影响因子：
8.8
作者：
Sellares, J.;de Freitas, D. G.;Halloran, P. F.
通讯作者：
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影响因子：
120.7
作者：
Tan, Jianming;Wu, Weizhen;Ricordi, Camillo
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影响因子：
8.8
作者：
Lion, J.;Taflin, C.;Mooney, N.
通讯作者：
Mooney, N.
DOI：
10.2215/cjn.04950610
发表时间：
2011-02-01
影响因子：
9.8
作者：
Perico, Norberto;Casiraghi, Federica;Remuzzi, Giuseppe
通讯作者：
Remuzzi, Giuseppe