Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT).

Background

To compare the efficacy of bone marrow-derived MSCs versus placebo in ARDS.

比较骨髓来源的MSCs与安慰剂在ARDS中的疗效。

Methods

Prospective, double-blind, multicenter, randomized phase 2b clinical trial of one dose of intravenous MSCs (10 × 106/kg predicted body weight) versus placebo in 120 ventilated patients with ARDS (PaO2/FiO2 ratio <250 mm Hg).

前瞻性、双盲、多中心、随机的2b期临床试验，比较单剂量静脉注射间充质干细胞（10 × 10^6/kg 预测体重）与安慰剂在120名接受机械通气的急性呼吸窘迫综合征（ARDS）患者（PaO2/FiO2 比率 <250 mm Hg）中的效果。

The primary endpoint was change in oxygenation index during the 36 hours after baseline.

主要终点是基线后36小时内氧合指数的变化。

measurements_and_main_results

Enrollment began in January 2020.

招募工作于2020年1月开始。

Because of the coronavirus disease (COVID-19) pandemic, ARDS developed from COVID-19 in the majority of subjects (101 of 120; 84%).

由于冠状病毒疾病（COVID-19）大流行，大多数受试者（120名中的101名；84%）发展为COVID-19相关的急性呼吸窘迫综合征（ARDS）。

There were no significant baseline differences in severity of illness between patients treated with MSCs and those who received placebo in the entire cohort of 120 patients or in the 101 patients with COVID-19 ARDS.

在接受MSCs治疗的患者与接受安慰剂的患者中，整体队列的120名患者或COVID-19 ARDS的101名患者在病情严重程度上没有显著的基线差异。

There were no differences in the primary endpoint of change in oxygenation index from baseline during the 36 hours after study product administration for the entire cohort or the COVID-19 subgroup, nor were there significant differences in mortality at 14, 28, 60, or 180 days.

在整体队列或COVID-19亚组中，研究产品给药后36小时内氧合指数从基线开始的变化这一主要终点没有差异，同样，在14天、28天、60天或180天的死亡率上也没有显著差异。

Plasma protein biomarker and gene expression analyses identified subgroups of patients with differential treatment responses in terms of clinical outcomes.

血浆蛋白生物标志物和基因表达分析确定了在临床结果方面具有不同治疗反应的患者亚组。

Conclusions

This phase 2b clinical trial identified no physiologic or clinical benefit from a single dose of MSCs in patients with ARDS, including those with COVID-19 ARDS.

这项2b期临床试验发现，对于包括COVID-19相关急性呼吸窘迫综合征（ARDS）患者在内的ARDS患者，单剂量间充质干细胞（MSCs）没有生理或临床益处。

In future trials, baseline plasma biological markers may help identify patients who are more likely to benefit from MSC therapy.Clinical trial registered with www.

在未来的试验中，基线血浆生物标志物可能有助于识别更可能从间充质干细胞（MSC）治疗中受益的患者。

clinicaltrials

gov (NCT03818854).

临床试验已在www.