The Effect of Mesenchymal Stromal Cells on the Mortality of Patients with Sepsis and Septic Shock: A Promising Therapy.
The Effect of Mesenchymal Stromal Cells on the Mortality of Patients with Sepsis and Septic Shock: A Promising Therapy.
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DOI：
10.1155/2022/9222379
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发表时间：
2022
影响因子：
1.2
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中科院分区：
文献类型：
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败血症和败血性休克是重症监护病房死亡的主要原因。本研究旨在评估间充质干细胞（MSC）在脓毒症和脓毒性休克患者中的临床安全性和有效性。 十名患者参加了该研究。与标准疗法一起给予脂肪源性MSC输注（1 × 106/kg，在治疗的第1、3、5、7和9天）。在 MSC 应用之前，收集血样用于细胞因子评估（TNF-α、IFN-γ、IL-2、IL-4、IL-6、IL-10）。记录临床和实验室改善情况，并与回顾性选择的对照组进行比较。该临床试验于2022年3月16日注册，注册号NCT05283317。 研究组中患者的年龄范围为22至68岁，APACHE II评分范围为14至42。对照组患者年龄范围为22至80岁，APACHE II评分范围为14至35。研究组的存活率在第14天时为100%，而在第28天时为70%。在 MSC 给药期间观察到 SOFA 评分（调整后）显着下降，临床和实验室改善。然而，没有观察到细胞因子水平的显着变化。对照组中，20名患者第14天的生存率为70%，而第28天的生存率为60%。对照组在治疗第一周观察到死亡，而 MSC 组则在第 15 天至 28 天之间观察到死亡。 间充质干细胞治疗可能对早期脓毒症的生存率产生积极影响。然而，需要对大量患者进行进一步的随机对照研究。试用注册。该试验已在 ClinicalTrials.gov 注册，标识符：NCT05283317。
Sepsis and septic shock are the major causes of death in intensive care units. This study aimed to evaluate the clinical safety and efficacy of mesenchymal stem cells (MSCs) in sepsis and septic shock patients. Ten patients were enrolled in the study. Adipose-derived MSC infusions were given (1 × 106/kg, on the 1st, 3rd, 5th, 7th, and 9th days of therapy) together with standard therapy. Before the MSC applications, blood samples were collected for cytokine assessment (TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10). The clinical and laboratory improvements were recorded and compared with control groups selected retrospectively. The clinical trial was registered on 16.03.2022 with the registration number NCT05283317. In the study group, the ages of patients ranged from 22 to 68 years, and APACHE II scores ranged from 14 to 42. In the control group, ages ranged from 22 to 80 years and their APACHE II scores were between 14–35. The survival rate in the study group was 100% on the 14th day whereas it was 70% on the 28th day. A significant decrease in the SOFA score (adjusted), clinical, and laboratory improvements were observed during the MSC administration. However, no significant cytokine level changes were observed. In the control group, the survival rate of 20 patients was 70% on the 14th day, whereas 60% was on the 28th day. While deaths were observed in the control group in the first week of treatment, deaths in the MSCs group were observed between the 15th and 28th days. MSCs treatment may have a positive impact on the survival rates of sepsis during the early phase. However, further randomized controlled studies with a large group of patients are needed. Trial Registration. This trial is registered with ClinicalTrials.gov Identifier: NCT05283317.
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