Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial.
Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial.
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DOI：
10.1002/sctm.20-0472
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发表时间：
2021-05
影响因子：
6
通讯作者：
Ricordi C
中科院分区：
文献类型：
--
作者：
Lanzoni G;Linetsky E;Correa D;Messinger Cayetano S;Alvarez RA;Kouroupis D;Alvarez Gil A;Poggioli R;Ruiz P;Marttos AC;Hirani K;Bell CA;Kusack H;Rafkin L;Baidal D;Pastewski A;Gawri K;Leñero C;Mantero AMA;Metalonis SW;Wang X;Roque L;Masters B;Kenyon NS;Ginzburg E;Xu X;Tan J;Caplan AI;Glassberg MK;Alejandro R;Ricordi C
新冠肺炎并发的急性呼吸窘迫综合征与高死亡率相关。已知间充质干细胞可发挥免疫调节和抗炎作用，并可在新冠肺炎急性呼吸窘迫综合征中产生有益效果。本研究的目的是确定脐带间充质干细胞输注治疗新冠肺炎急性呼吸窘迫综合征的安全性和有效性。采用1/2a期双盲随机对照试验。ARDS严重程度的随机化和分层被用来促进组间的平衡。所有受试者均按意向处理设计进行分析。24名受试者被随机分为UC-MSC治疗组(n=12)和对照组(n=12)。UC-MSCs治疗组于第0天和第3天两次静脉输注100 ± 20 × 106 UC-MSCs，对照组两次输注载体液。两组都得到了最好的护理标准。主要终点是6小时内的安全性(不良事件)；输注后24 小时内心脏骤停或死亡)。次要终点包括患者在第一次输液后31 天的存活时间和恢复时间。在输液相关不良反应方面，两组之间没有差异。未观察到与UC-MSC输注相关的严重不良事件(SAE)。新冠肺炎急性呼吸窘迫综合征患者输注UC-MSC是安全的。接受UC-MSCs治疗的受试者在第6天炎性细胞因子显著减少。治疗与显著改善患者存活率(91%比42%，P= .015)、无SAE存活率(P= .008)和恢复时间(P= .03)有关。UC-MSC输注是安全的，可能有益于新冠肺炎ARDS患者的治疗。
Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti‐inflammatory effects and could yield beneficial effects in COVID‐19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC‐MSC) infusions in subjects with COVID‐19 ARDS. A double‐blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty‐four subjects were randomized 1:1 to either UC‐MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC‐MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC‐MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion‐associated AEs. No serious adverse events (SAEs) were observed related to UC‐MSC infusions. UC‐MSC infusions in COVID‐19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC‐MSC‐treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE‐free survival (P = .008), and time to recovery (P = .03). UC‐MSC infusions are safe and could be beneficial in treating subjects with COVID‐19 ARDS.
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