Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
ATMP Department, Breast Cancer Research Center, Motamed Cancer Institute, ACECR, P.O. BOX: 15179/64311, Tehran, Iran.
Stem Cell Res Ther. 2022 Jul 28;13(1):365. doi: 10.1186/s13287-022-02953-6.
High morbidity and mortality rates of the COVID-19 pandemic have made it a global health priority. Acute respiratory distress syndrome (ARDS) is one of the most important causes of death in COVID-19 patients. Mesenchymal stem cells have been the subject of many clinical trials for the treatment of ARDS because of their immunomodulatory, anti-inflammatory, and regenerative potentials. The aim of this phase I clinical trial was the safety assessment of allogeneic placenta-derived mesenchymal stem cells (PL-MSCs) intravenous injection in patients with ARDS induced by COVID-19.
We enrolled 20 patients suffering from ARDS caused by COVID-19 who had been admitted to the intensive care unit. PL-MSCs were isolated and propagated using a xeno-free/GMP compliant protocol. Each patient in the treatment group (N = 10) received standard treatment and a single dose of 1 × 10 cells/kg PL-MSCs intravenously. The control groups (N = 10) only received the standard treatment. Clinical signs and laboratory tests were evaluated in all participants at the baseline and during 28 days follow-ups.
No adverse events were observed in the PL-MSC group. Mean length of hospitalization, serum oxygen saturation, and other clinical and laboratory parameters were not significantly different in the two groups (p > 0.05).
Our results demonstrated that intravenous administration of PL-MSCs in patients with COVID-19 related ARDS is safe and feasible. Further studies whit higher cell doses and repeated injections are needed to evaluate the efficacy of this treatment modality.
Iranian Registry of Clinical Trials (IRCT); IRCT20200621047859N4. Registered 1 March 2021, https://en.irct.ir/trial/52947 .
COVID-19 大流行的高发病率和死亡率使其成为全球卫生重点。急性呼吸窘迫综合征（ARDS）是 COVID-19 患者死亡的最重要原因之一。间充质干细胞因其具有免疫调节、抗炎和再生潜力，已成为治疗 ARDS 的许多临床试验的主题。这项 I 期临床试验的目的是评估同种异体胎盘来源间充质干细胞（PL-MSCs）静脉注射治疗 COVID-19 引起的 ARDS 的安全性。
我们招募了 20 名因 COVID-19 而患有 ARDS 的患者，这些患者已入住重症监护病房。PL-MSCs 是使用无动物源/GMP 兼容的方案分离和扩增的。治疗组（N=10）中的每位患者接受标准治疗和单次 1×10 个细胞/kg PL-MSCs 静脉注射。对照组（N=10）仅接受标准治疗。所有参与者在基线和 28 天随访期间评估临床体征和实验室检查。
PL-MSC 组未观察到不良事件。两组的平均住院时间、血清氧饱和度和其他临床及实验室参数均无显著差异（p>0.05）。
我们的结果表明，COVID-19 相关 ARDS 患者静脉注射 PL-MSCs 是安全可行的。需要更高细胞剂量和重复注射的进一步研究来评估这种治疗方式的疗效。
伊朗临床试验注册处（IRCT）；IRCT20200621047859N4。于 2021 年 3 月 1 日注册，https://en.irct.ir/trial/52947 。
Zotero 插件
