Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial.
Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial.
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DOI：
10.1038/s41392-021-00488-5
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发表时间：
2021-02-10
影响因子：
39.3
通讯作者：
Wang FS
中科院分区：
文献类型：
--
作者：
Shi L;Huang H;Lu X;Yan X;Jiang X;Xu R;Wang S;Zhang C;Yuan X;Xu Z;Huang L;Fu JL;Li Y;Zhang Y;Yao WQ;Liu T;Song J;Sun L;Yang F;Zhang X;Zhang B;Shi M;Meng F;Song Y;Yu Y;Wen J;Li Q;Mao Q;Maeurer M;Zumla A;Yao C;Xie WF;Wang FS
严重冠状病毒病2019年的治疗(新冠肺炎)具有挑战性。基于我们的第一阶段数据，我们进行了第二阶段的试验，以评估人脐带间充质干细胞(UC-MSCs)治疗严重新冠肺炎肺损伤患者的有效性和安全性。在这项随机、双盲、安慰剂对照试验中，我们招募了101名严重的新冠肺炎肺损害患者。他们按2：1的比例随机分配，在第0、3和6天接受UC-MSCs(每次输注4个 × 107细胞)或安慰剂。主要终点是从基线到第28天全肺病变体积的改变比例。记录和分析其他影像结果、6分钟步行试验(6-MWT)、最大肺活量、弥散量和不良事件。总共有100名新冠肺炎患者最终接受了UC-MSCs(n = 65人)或安慰剂(n = 35人)。从基线到第28天，UC-MSCs组的全肺病变体积与安慰剂组相比有明显的改善(中位数差值分别为−13.31%，95%CI−29.14%，2.13%，P = 0.080)。与安慰剂组相比，UC-MSCs的实体成分损伤体积比例显著减少(中位数差异：−15.45%；95%CI−30.82%，−0.39%；P = 0.043)。接受UC-MSCs治疗的患者6-MWT的距离增加(差值：27.00 m；95%可信区间0.00，57.00；P = 0.057)。两组不良事件发生率相似。这些结果表明，UC-MSCs治疗新冠肺炎肺损害是一种安全且潜在有效的治疗方法。需要进行3期试验，以评估降低死亡率和预防长期肺部残疾的效果。(由中国等人国家重点研发计划资助。ClinicalTrials.gov编号，NCT04288102。
Treatment of severe Coronavirus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test (6-MWT), maximum vital capacity, diffusing capacity, and adverse events were recorded and analyzed. In all, 100 COVID-19 patients were finally received either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was −13.31%, 95% CI −29.14%, 2.13%, P = 0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: −15.45%; 95% CI −30.82%, −0.39%; P = 0.043). The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057). The incidence of adverse events was similar in the two groups. These results suggest that UC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. A phase 3 trial is required to evaluate effects on reducing mortality and preventing long-term pulmonary disability. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.
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DOI：
10.1056/nejmoa2022926
发表时间：
2020-11-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
RECOVERY Collaborative Group;Horby P;Mafham M;Linsell L;Bell JL;Staplin N;Emberson JR;Wiselka M;Ustianowski A;Elmahi E;Prudon B;Whitehouse T;Felton T;Williams J;Faccenda J;Underwood J;Baillie JK;Chappell LC;Faust SN;Jaki T;Jeffery K;Lim WS;Montgomery A;Rowan K;Tarning J;Watson JA;White NJ;Juszczak E;Haynes R;Landray MJ
通讯作者：
Landray MJ
DOI：
10.1016/s2213-2600(18)30418-1
发表时间：
2019-03
期刊：
The Lancet. Respiratory medicine
影响因子：
--
作者：
Matthay MA;Calfee CS;Zhuo H;Thompson BT;Wilson JG;Levitt JE;Rogers AJ;Gotts JE;Wiener-Kronish JP;Bajwa EK;Donahoe MP;McVerry BJ;Ortiz LA;Exline M;Christman JW;Abbott J;Delucchi KL;Caballero L;McMillan M;McKenna DH;Liu KD
通讯作者：
Liu KD
影响因子：
12.8
作者：
Chen, Jiajia;Hu, Chenxia;Li, Lanjuan
通讯作者：
Li, Lanjuan
影响因子：
120.7
作者：
Li, Ling;Zhang, Wei;Liu, Zhong
通讯作者：
Liu, Zhong
影响因子：
30.5
作者：
Zhang, Ji-Yuan;Wang, Xiang-Ming;Wang, Fu-Sheng
通讯作者：
Wang, Fu-Sheng