脐带和胎盘来源的间充质干细胞静脉注射治疗中度新型冠状病毒肺炎患者的1期临床试验：研究第1阶段结果
Phase 1 clinical trial for intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with moderate COVID-19 virus pneumonia: results of stage 1 of the study.
作者信息
Sharma Alok, Kulkarni Rohit, Sane Hemangi, Awad Nilkanth, Bopardikar Abhijit, Joshi Anagha, Baweja Sujata, Joshi Mohan, Vishwanathan Chandra, Gokulchandran Nandini, Badhe Prerna, Khan Mazhar, Paranjape Amruta, Kulkarni Pooja, Methal Arjun K
机构信息
Department of Neurosurgery, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Department of Medical Services and Clinical Research, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
出版信息
Am J Stem Cells. 2022 Jun 15;11(3):37-55. eCollection 2022.
OBJECTIVE
Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage.
METHOD
Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed.
RESULTS
No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention.
CONCLUSION
Administration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175.
目的
间充质干细胞可作为治疗新冠肺炎的一种选择。其免疫调节和抗炎特性可调节过度的炎症反应并促进肺损伤的恢复。
方法
开展了一项1期、单中心、开放标签的前瞻性临床试验，以评估静脉输注源自脐带和胎盘的间充质干细胞治疗中度新冠肺炎的安全性和有效性。该研究分两个阶段进行，共有20名患者。本文讨论了第一阶段的结果，包括首批10名患者在第1天和第4天接受1亿个细胞治疗，并随访6个月。
结果
在输注间充质干细胞后即刻或随访期间均未记录到不良事件。临床、实验室和影像学参数均未出现恶化。研究组的所有症状在10天内均得到缓解。干预后，所有患者的炎症生物标志物如中性粒细胞与淋巴细胞比值（NLR）、C反应蛋白（CRP）、白细胞介素6（IL6）、铁蛋白和D-二聚体水平均有所改善，同时氧合改善，表现为血氧饱和度/吸入氧分数值（SpO2/FiO2）和动脉血氧分压/吸入氧分数值（PaO2/FiO2）升高。所有患者均未进展至重症阶段。10名患者中有9名在入院后9天内出院。大多数患者在第7天的胸部X光和胸部CT扫描评分有所改善。干预后28天的胸部CT以及干预6个月后的胸部X光检查均未发现新冠后肺纤维化。
结论
发现联合标准治疗输注1亿个间充质干细胞是安全的，可预防细胞因子风暴，阻止疾病进展，并加速中度新冠肺炎的康复。该临床试验已在印度临床试验注册中心（CTRI）注册，注册号为CTRI/2020/08/027043。http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175 。
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