干细胞治疗新冠肺炎6天控制 两周内病变消失
时间:2020-09-05
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间充质干细胞(MSC)作为干细胞家族的重要成员,属于多能干细胞,来源于发育早期的中胚层。研究发现:1.MSC具有归巢效应,可以使其更多的富集在病灶处;2.MSC具有旁分泌效应,发挥免疫调节作用,调节病灶处的炎症反应;3.MSC具有组织修复效应,能够分泌修复因子促进损伤部位组织修复。这使得MSC在治疗新冠肺炎中占据一定优势,成为救治重症新冠肺炎患者的重要策略之一。
2020年伊始,新型冠状病毒疫情在中国暴发,并迅速在世界范围内蔓延。随着疫情的发展变化,全球感染人数已达千万级别。因此,为新冠肺炎患者开发出有效的治疗药物,以挽救患者性命就十分关键。尤其在《人民日报》公开宣称:“干细胞对新冠肺炎显示出特有的治疗效果“之后,全球对于干细胞治疗新冠肺炎的临床研究开展得更是如火如荼。
中国科学院院士、全军传染病研究所所长、国家干细胞临床研究专家委员会委员王福生带领团队第一时间对间充质干细胞治疗新冠肺炎临床研究展开应急攻关。近日,干细胞治疗新冠肺炎I期临床研究结果刊登在Nature子刊上,初步证实脐带间充质干细胞(UC-MSC)对于普通型和重型新冠肺炎患者的安全性和临床益处。该干细胞项目获得了国家科技部公共安全风险防控与应急技术装备应急科研攻关重大专项支持,并获得了军队新冠疫情紧急研究备案支持。
该临床研究按照平行分配的对照和非随机原则,共纳入了18例住院的新冠肺炎患者。治疗组在第0、3、6天接受静脉输注UC-MSCs ,剂量为3X107个细胞。所使用的间充质干细胞制剂由中源协和细胞基因工程股份有限公司制备提供。治疗组接受UC-MSCs输注无严重不良反应。安全性研究认为:治疗组接受UC-MSCs输注无严重不良反应,UC-MSCs用于治疗新冠肺炎患者安全且耐受;有效性研究表明:接受UC-MSCs输注的患者肺部病变在6天内得到了很好的控制,并在UC-MSCs输注后2周内病变完全消失;在随访期内,全部18例患者康复出院。课题组后续将进行II/III期研究,计划招募90位患者,通过随机双盲安慰剂对照试验(RCT)和长期随访,评估UC-MSCs在重型新冠肺炎患者中的有效性和治疗效果。
间充质干细胞(MSC)作为干细胞家族的重要成员,属于多能干细胞,来源于发育早期的中胚层。研究发现:1.MSC具有归巢效应,可以使其更多的富集在病灶处;2.MSC具有旁分泌效应,发挥免疫调节作用,调节病灶处的炎症反应;3.MSC具有组织修复效应,能够分泌修复因子促进损伤部位组织修复。这使得MSC在治疗新冠肺炎中占据一定优势,成为救治重症新冠肺炎患者的重要策略之一。
参考资料:
Abstract:No effective drug treatments areavailable for coronavirus disease 2019 (COVID-19). Host-directed therapiestargeting the underlying aberrant immune responses leading to pulmonary tissuedamage, death, or long-term functional disability in survivors require clinicalevaluation. We performed a parallel assigned controlled, non-randomized, phase1 clinical trial to evaluate the safety of human umbilical cord-derivedmesenchymal stem cells (UC-MSCs) infusions in the treatment of patients withmoderate and severe COVID-19 pulmonary disease. The study enrolled 18hospitalized patients with COVID-19 (n = 9 for each group). The treatment groupreceived three cycles of intravenous infusion of UC-MSCs (3 × 107 cells perinfusion) on days 0, 3, and 6. Both groups received standard COVID-treatmentregimens. Adverse events, duration of clinical symptoms, laboratory parameters,length of hospitalization, serial chest computed tomography (CT) images, thePaO2/FiO2 ratio, dynamics of cytokines, and IgG and IgM anti-SARS-CoV-2antibodies were analyzed. No serious UC-MSCs infusion-associated adverse eventswere observed. Two patients receiving UC-MSCs developed transient facialflushing and fever, and one patient developed transient hypoxia at 12 h postUC-MSCs transfusion. Mechanical ventilation was required in one patient in thetreatment group compared with four in the control group. All patients recoveredand were discharged. Our data show that intravenous UC-MSCs infusion inpatients with moderate and severe COVID-19 is safe and well tolerated. Phase2/3 randomized, controlled, double-blinded trials with long-term follow-up areneeded to evaluate the therapeutic use of UC-MSCs to reduce deaths and improvelong-term treatment outcomes in patients with serious COVID-19. (信息来源:医麦客)