Lapuente Juan Pedro, Gómez Gonzalo, Marco-Brualla Joaquín, Fernández Pablo, Desportes Paula, Sanz Jara, García-Gil Mario, Bermejo Fernando, San Martín Juan Víctor, Algaba Alicia, De Gregorio Juan Carlos, Lapuente Daniel, De Gregorio Almudena, Lapuente Belén, Gómez Sergio, Andrés María de Las Viñas, Anel Alberto
R4T Molecular and Cell Biology Research Laboratories, Fuenlabrada Hospital, 28942 Madrid, Spain.
Group Immunity, Cancer and Stem Cells, Faculty of Sciences, University of Zaragoza, 50009 Zaragoza, Spain.
Biomedicines. 2022 May 8;10(5):1094. doi: 10.3390/biomedicines10051094.
Our research group has been developing a series of biological drugs produced by coculture techniques with M2-polarized macrophages with different primary tissue cells and/or mesenchymal stromal cells (MSC), generally from fat, to produce anti-inflammatory and anti-fibrotic effects, avoiding the overexpression of pro-inflammatory cytokines by the innate immune system at a given time. One of these products is the drug PRS CK STORM, a medium conditioned by allogenic M2-polarized macrophages, from coculture, with those macrophages M2 with MSC from fat, whose composition, in vitro safety, and efficacy we studied. In the present work, we publish the results obtained in terms of safety (pharmacodynamics and pharmacokinetics) and efficacy of the intravenous application of this biological drug in a murine model of cytokine storm associated with severe infectious processes, including those associated with COVID-19. The results demonstrate the safety and high efficacy of PRS CK STORM as an intravenous drug to prevent and treat the cytokine storm associated with infectious processes, including COVID-19.
我们的研究小组一直在开发一系列生物药物,这些药物是通过将M2极化巨噬细胞与不同的原代组织细胞和/或间充质基质细胞(MSC,通常来自脂肪)共培养技术生产的,以产生抗炎和抗纤维化作用,避免先天性免疫系统在特定时间过度表达促炎细胞因子。其中一种产品是药物PRS CK STORM,它是一种由同种异体M2极化巨噬细胞与来自脂肪的MSC共培养条件化的培养基,我们研究了其组成、体外安全性和功效。在本研究中,我们公布了在与严重感染过程相关的细胞因子风暴小鼠模型(包括与COVID-19相关的模型)中静脉应用这种生物药物的安全性(药效学和药代动力学)和功效方面所获得的结果。结果表明,PRS CK STORM作为一种静脉药物,在预防和治疗与包括COVID-19在内的感染过程相关的细胞因子风暴方面具有安全性和高效性。