间充质干细胞治疗失代偿期肝硬化：随机对照临床试验的长

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间充质干细胞治疗失代偿期肝硬化：随机对照临床试验的长期随访分析

    Ming Shi、Yuan-Yuan Li、Ruo-Nan Xu、Fan-Ping Meng、Shuang-Jie Yu、Jun-Liang Fu、Jin-Hua Hu、Jing-Xin Li、Li-Feng Wang、Lei Jin & Fu-Sheng Wang

Hepatology International 第 15 卷，第 1431–1441 页（2021）引用本文

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抽象的
背景

据报道，间充质干细胞 (MSC) 输注可改善失代偿性肝硬化 (DLC) 患者的肝功能；然而，人们对药物是否能改善这些患者的预后知之甚少。
方法

这项前瞻性、开放标签、随机对照研究招募了 219 名 HBV 相关 DLC 患者，他们分为对照组（n = 111）和脐带源性 MSC（UC-MSC）治疗组（n = 108），然后均于2010年10月至2017年10月接受随访检查。治疗组患者接受3次UC-MSC输注，间隔4周，外加仅用于对照组的常规治疗。计算总生存率和无 HCC 生存率作为主要终点，并评估与药物相关的肝功能和不良事件。
结果

13～75个月随访检查期间，治疗组总生存率明显高于对照组，而治疗组与对照组肝细胞癌无事件生存率差异不显着。在 75 个月的随访期间观察到。 UC-MSC 治疗显着改善了肝功能，如在 48 周随访期间血清白蛋白、凝血酶原活性、胆碱酯酶和总胆红素水平所示。在 UC-MSC 组中没有观察到显着的副作用或治疗相关的并发症。
结论

UC-MSC 治疗不仅耐受性好，而且显着提高了长期生存率，以及 HBV 相关 DLC 患者的肝功能。因此，UC-MSC 药物可能为该疾病提供一种新的治疗方法。

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Mesenchymal stem cell therapy in decompensated liver cirrhosis: a long-term follow-up analysis of the randomized controlled clinical trial

    Ming Shi, Yuan-Yuan Li, Ruo-Nan Xu, Fan-Ping Meng, Shuang-Jie Yu, Jun-Liang Fu, Jin-Hua Hu, Jing-Xin Li, Li-Feng Wang, Lei Jin & Fu-Sheng Wang

Hepatology International volume 15, pages 1431–1441 (2021)Cite this article

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Abstract
Background

Mesenchymal stem cell (MSC) infusion was reported to improve liver function in patients with decompensated liver cirrhosis (DLC); however, whether the medication can improve outcome of these patients is poorly understood.
Methods

This prospective, open-labeled, randomized controlled study enrolled 219 patients with HBV-related DLC who were divided into control group (n = 111) and umbilical cord-derived MSC (UC-MSC)-treated group (n = 108), then all of them received a follow-up check from October 2010 to October 2017. The treated patients received three times of UC-MSC infusions at 4-week intervals plus conventional treatment that was only used for control group. The overall survival rate and HCC-free survival rate were calculated as primary endpoints and the liver function and adverse events associated with the medication were also evaluated.
Results

During the follow-up check period from 13 to 75th months, there was a significantly higher overall survival rate in the treated group than the control group, while the difference of the hepatocellular carcinoma event-free survival rate between the treated and control groups was not observed during the 75-month follow-up. UC-MSC treatment markedly improved liver function, as indicated by the levels of serum albumin, prothrombin activity, cholinesterase, and total bilirubin during 48 weeks of follow-up. No significant side effects or treatment-related complications were observed in the UC-MSC group.
Conclusions

Therapy of UC-MSC is not only well tolerated, but also significantly improves long-term survival rate, as well as the liver function in patients with HBV-related DLC. UC-MSC medication, therefore, might present a novel therapeutic approach for the disease.

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https://link.springer.com/articl ... c_springer_20211208