Department of Nephrology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
Cytotherapy. 2018 May;20(5):660-669. doi: 10.1016/j.jcyt.2018.02.368. Epub 2018 Mar 23.
Chronic kidney disease (CKD) is a progressive loss of kidney function and structure that affects approximately 13% of the population worldwide. A recent meta-analysis revealed that cell-based therapies improve impaired renal function and structure in preclinical models of CKD. We assessed the safety and tolerability of bone marrow-mesenchymal stromal cell (MSC) infusion in patients with CKD.
A single-arm study was carried out at one center with 18-month follow-up in seven eligible patients with CKD due to different etiologies such as hypertension, nephrotic syndrome (NS) and unknown etiology. We administered an intravenous infusion (1-2 × 10 cells/kg) of autologous cultured MSCs. The primary endpoint was safety, which was measured by number and severity of adverse events. The secondary endpoint was decrease in the rate of decrease in estimated glomerular filtration rate (eGFR). We compared kidney function during the follow-up visits to baseline and 18 months prior to the intervention.
Follow-up visits of all seven patients were completed; however, we have not observed any cell-related adverse events during the trial. Changes in eGFR (P = 0.10) and serum creatinine (P = 0.24) from 18 months before cell infusion to baseline in comparison with baseline to 18 months were not statistically significant.
We showed safety and tolerability of a single-dose infusion of autologous MSCs in patients with CKD.
慢性肾脏病（CKD）是一种肾脏功能和结构进行性丧失的疾病，影响着全球约 13%的人口。最近的一项荟萃分析显示，细胞疗法可改善 CKD 动物模型中受损的肾功能和结构。我们评估了骨髓间充质干细胞（MSC）输注治疗 CKD 患者的安全性和耐受性。
在一家中心进行了一项单臂研究，对 7 名因不同病因（如高血压、肾病综合征（NS）和病因不明）导致 CKD 的合格患者进行了 18 个月的随访。我们给予患者自体培养的 MSC 静脉输注（1-2×10 个细胞/kg）。主要终点是安全性，通过不良事件的数量和严重程度来衡量。次要终点是估计肾小球滤过率（eGFR）下降率的降低。我们比较了随访期间与基线和干预前 18 个月的肾功能。
所有 7 名患者均完成了随访，但在试验过程中未观察到任何与细胞相关的不良事件。与基线相比，eGFR（P=0.10）和血清肌酐（P=0.24）从细胞输注前 18 个月到基线的变化以及从基线到 18 个月的变化均无统计学意义。
我们表明，单次输注自体 MSC 治疗 CKD 患者是安全且耐受的。
