Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.
Department of Respiratory Medicine, the Second Clinical Medical School of Nanjing Medical University, Nanjing, 210011, Jiangsu, China.
Stem Cell Res Ther. 2020 Aug 18;11(1):361. doi: 10.1186/s13287-020-01875-5.
COVID-19 is a highly infectious respiratory disease. No therapeutics have yet been proven effective for treating severe COVID-19.
To determine whether human umbilical cord mesenchymal stem cell infusion may be effective and safe for the treatment of severe COVID-19.
Patients with severe COVID-19 were randomly divided into 2 groups: the standard treatment group and the standard treatment plus hUC-MSC infusion group. The incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes were observed and compared between the two groups.
The incidence of progression from severe to critical illness and the 28-day mortality rate were 0 in the hUC-MSC treatment group, while 4 patients in the control group deteriorated to critical condition and received invasive ventilation; 3 of them died, and the 28-day mortality rate was 10.34%. In the hUC-MSC treatment group, the time to clinical improvement was shorter than that in the control group. Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation obviously improved beginning on the third day of stem cell infusion and reached a significant difference on day 7. CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
Intravenous transplantation of hUC-MSCs is a safe and effective method that can be considered a salvage and priority treatment option for severe COVID-19.
Chinese Clinical Trial Registration; ChiCTR2000031494; Registered on 2 April 2020; http:// www.medresman.org.
COVID-19 是一种高度传染性的呼吸道疾病。目前尚无有效的治疗严重 COVID-19 的药物。
确定人脐带间充质干细胞输注是否可有效治疗严重 COVID-19 并确保安全。
将严重 COVID-19 患者随机分为两组：标准治疗组和标准治疗加 hUC-MSC 输注组。观察并比较两组患者从重症进展为危重症的发生率、28 天死亡率、临床症状改善、临床症状改善时间、包括 C 反应蛋白、淋巴细胞数和白细胞介素 6 在内的血液学指标以及影像学变化。
hUC-MSC 治疗组无一例从重症进展为危重症，对照组有 4 例患者病情恶化至危重症并接受有创通气；其中 3 例死亡，28 天死亡率为 10.34%。hUC-MSC 治疗组临床改善时间短于对照组。干细胞输注后第 3 天开始，乏力、呼吸困难、低氧饱和度等临床症状明显改善，第 7 天达到显著差异。hUC-MSC 组 CRP 和 IL-6 水平从输注第 3 天起明显降低，淋巴细胞计数恢复正常的时间明显加快，CT 影像学上肺部炎症吸收明显快于对照组。
静脉输注 hUC-MSCs 是一种安全有效的方法，可作为严重 COVID-19 的抢救和优先治疗选择。
中国临床试验注册中心；ChiCTR2000031494；于 2020 年 4 月 2 日注册；http://www.medresman.org.
