The Systematic Effect of Mesenchymal Stem Cell Therapy in Critical COVID-19 Patients: A Prospective Double Controlled Trial.
The Systematic Effect of Mesenchymal Stem Cell Therapy in Critical COVID-19 Patients: A Prospective Double Controlled Trial.
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DOI：
10.1177/09636897211024942
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发表时间：
2021-01
影响因子：
3.3
通讯作者：
Karaoz E
中科院分区：
文献类型：
--
作者：
Adas G;Cukurova Z;Yasar KK;Yilmaz R;Isiksacan N;Kasapoglu P;Yesilbag Z;Koyuncu ID;Karaoz E
这项临床试验的目的是通过向重症COVID-19患者施用间充质干细胞（MSC）来控制细胞因子风暴，评估愈合效果，并系统地研究治疗如何起作用。具有中度和危重COVID-19临床表现的患者被分为第1组（中度病例，n = 10，常规治疗），第2组（危重病例，n = 10，常规治疗）和组3（危重病例，n = 10，常规治疗加在治疗第0、3和6天连续三次剂量的MSC移植治疗，（3 × 106个细胞/kg，静脉注射）。通过生物化学参数、促炎和抗炎细胞因子水平、生长因子、凋亡标志物、趋化因子、基质金属蛋白酶和颗粒酶-B水平对组织再生进行分析，并通过总氧化/抗氧化状态标志物和淋巴细胞亚群水平评估免疫调节作用，研究了治疗作用机制。在评估所有病例的总体死亡率时，第2组中有6名患者死亡，第3组中有3名患者死亡，第1组中没有死亡。在第3组中发现促炎细胞因子IFNγ、IL-6、IL-17 A、IL-2、IL-12、抗炎细胞因子IL-10、IL-13、IL-1 ra和生长因子TGF-β、VEGF、KGF和NGF水平显著。当组2和组3比较时，组3的血清铁蛋白、纤维蛋白原和CRP水平显著降低。评价了CD 45+、CD 3+、CD 4+、CD 8+、CD 19+、HLA-DR +和CD 16 + /CD 56+水平。在各组的统计学比较中，仅确定了中性粒细胞的显著性。结果证明了MSC应用于重症COVID-19患者的积极系统和细胞效应。这种效应在治愈和降低危重患者死亡率方面起着重要作用。
The aim of this clinical trial was to control the cytokine storm by administering mesenchymal stem cells (MSCs) to critically-ill COVID-19 patients, to evaluate the healing effect, and to systematically investigate how the treatment works. Patients with moderate and critical COVID-19 clinical manifestations were separated as Group 1 (moderate cases, n = 10, treated conventionally), Group 2 (critical cases, n = 10, treated conventionally), and Group 3 (critical cases, n = 10, treated conventionally plus MSCs transplantation therapy of three consecutive doses on treatment days 0, 3, and 6, (as 3 × 106 cells/kg, intravenously). The treatment mechanism of action was investigated with evaluation markers of the cytokine storm, via biochemical parameters, levels of proinflammatory and anti-inflammatory cytokines, analyses of tissue regeneration via the levels of growth factors, apoptosis markers, chemokines, matrix metalloproteinases, and granzyme-B, and by the assessment of the immunomodulatory effects via total oxidant/antioxidant status markers and the levels of lymphocyte subsets. In the assessment of the overall mortality rates of all the cases, six patients in Group-2 and three patients in Group-3 died, and there was no loss in Group-1. Proinflammatory cytokines IFNγ, IL-6, IL-17A, IL-2, IL-12, anti-inflammatory cytokines IL-10, IL-13, IL-1ra, and growth factors TGF-β, VEGF, KGF, and NGF levels were found to be significant in Group-3. When Group-2 and Group-3 were compared, serum ferritin, fibrinogen and CRP levels in Group-3 had significantly decreased. CD45 +, CD3 +, CD4 +, CD8 +, CD19 +, HLA-DR +, and CD16 + / CD56 + levels were evaluated. In the statistical comparison of the groups, significance was only determined in respect of neutrophils. The results demonstrated the positive systematic and cellular effects of MSCs application on critically ill COVID-19 patients in a versatile way. This effect plays an important role in curing and reducing mortality in critically ill patients.
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