Umbilical cord mesenchymal stromal cells as critical COVID-19 adjuvant therapy: A randomized controlled trial.

Umbilical cord mesenchymal stromal cells as critical COVID-19 adjuvant therapy: A randomized controlled trial.
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脐带间充质基质细胞作为关键的COVID-19辅助治疗:一项随机对照试验。

DOI:
10.1002/sctm.21-0046
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发表时间:
2021-09
影响因子:
6
通讯作者:
Rahmatika D
Rahmatika D
中科院分区:
医学2区
文献类型:
--
作者:
Dilogo IH;Aditianingsih D;Sugiarto A;Burhan E;Damayanti T;Sitompul PA;Mariana N;Antarianto RD;Liem IK;Kispa T;Mujadid F;Novialdi N;Luviah E;Kurniawati T;Lubis AMT;Rahmatika D

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2019冠状病毒病(COVID - 19)急性呼吸窘迫综合征的主要原因之一是细胞因子风暴,尽管确切原因尚不清楚。脐带间充质间质细胞(UC - MSCs)影响促炎T -辅助2 (Th2)细胞向抗炎剂的转变。为了研究UC - MSC作为COVID - 19危重患者辅助治疗的疗效,我们在印度尼西亚雅加达的四家COVID - 19转诊医院进行了一项双盲、多中心、随机对照试验。该研究纳入了40例随机分配的COVID - 19危重患者;20例患者静脉输注1 × 106/kg体重UC - MSCs加入100 ml 0.9%生理盐水溶液(SS), 20例患者静脉输注100 ml 0.9%生理盐水溶液(SS)作为对照组。所有患者均接受标准治疗。主要结局以生存率和/或呼吸机使用时间长短来衡量。次要结局通过临床和实验室改善来衡量,有严重的不良事件。我们的研究显示,UC - MSCs组的生存率是对照组的2.5倍(P = 0.047), UC - MSCs组和对照组分别为10例和4例患者。在有合并症的患者中,与对照组相比,UC - MSC治疗使生存率提高了4.5倍。重症监护病房的住院时间和呼吸机的使用没有统计学意义,没有不良事件的报道。输注UC‐MSCs显著降低了康复患者的白细胞介素6 (P = 0.023)。因此,静脉注射UC - MSCs作为COVID - 19危重患者的辅助治疗可以通过调节免疫系统进入抗炎状态来提高生存率。COVID - 19患者的急性呼吸窘迫综合征是由细胞因子风暴引起的。脐带间充质间质细胞(UC - MSC)影响促炎Th2细胞向抗炎剂的转变。实验组给予UC - MSC输注,对照组给予生理盐水。我们的结果显示,通过调节免疫系统达到抗炎状态,实验组的存活率显着提高2.5倍。
One of the main causes of acute respiratory distress syndrome in coronavirus disease 2019 (COVID‐19) is cytokine storm, although the exact cause is still unknown. Umbilical cord mesenchymal stromal cells (UC‐MSCs) influence proinflammatory T‐helper 2 (Th2) cells to shift to an anti‐inflammatory agent. To investigate efficacy of UC‐MSC administration as adjuvant therapy in critically ill patients with COVID‐19, we conducted a double‐blind, multicentered, randomized controlled trial at four COVID‐19 referral hospitals in Jakarta, Indonesia. This study included 40 randomly allocated critically ill patients with COVID‐19; 20 patients received an intravenous infusion of 1 × 106/kg body weight UC‐MSCs in 100 ml saline (0.9%) solution (SS) and 20 patients received 100 ml 0.9% SS as the control group. All patients received standard therapy. The primary outcome was measured by survival rate and/or length of ventilator usage. The secondary outcome was measured by clinical and laboratory improvement, with serious adverse events. Our study showed the survival rate in the UC‐MSCs group was 2.5 times higher than that in the control group (P = .047), which is 10 patients and 4 patients in the UC‐MSCs and control groups, respectively. In patients with comorbidities, UC‐MSC administration increased the survival rate by 4.5 times compared with controls. The length of stay in the intensive care unit and ventilator usage were not statistically significant, and no adverse events were reported. The application of infusion UC‐MSCs significantly decreased interleukin 6 in the recovered patients (P = .023). Therefore, application of intravenous UC‐MSCs as adjuvant treatment for critically ill patients with COVID‐19 increases the survival rate by modulating the immune system toward an anti‐inflammatory state. Acute respiratory distress syndrome in COVID‐19 patients is caused by a cytokine strom. Umbilical cord mesenchymal stromal cell (UC‐MSC) influence proinflammatory Th2 cells to shift to an anti‐inflammatory agent. An UC‐MSC infusion was given for the experimental group, and normal saline for the control group. Our result showed 2.5 times significantly higher survival rate in the experimental group that achieved by modulating the immune system toward anti‐inflammatory state.
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