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First-in-human use of a marine oxygen carrier (M101) for organ preservation: A safety and proof-of-principle study.
American Journal of Transplantation ( IF 8.8 ) Pub Date : 2020-02-03 , DOI: 10.1111/ajt.15798
Yannick Le Meur 1, 2 , Lionel Badet 3 , Marie Essig 4 , Antoine Thierry 5 , Matthias Büchler 6 , Sarah Drouin 7 , Charles Deruelle 8 , Emmanuel Morelon 9 , Francis Pesteil 10 , Pierre-Olivier Delpech 11 , Jean-Michel Boutin 12 , Felix Renard 1 , Benoit Barrou 7
Affiliation  

The medical device M101 is an extracellular hemoglobin featuring high oxygen-carrying capabilities. Preclinical studies demonstrated its safety as an additive to organ preservation solutions and its beneficial effect on ischemia/reperfusion injuries. OXYgen carrier for Organ Preservation (OXYOP) is a multicenter open-label study evaluating for the first time the safety of M101 added (1 g/L) to the preservation solution of one of two kidneys from the same donor. All adverse events (AEs) were analyzed by an independent data and safety monitoring board. Among the 58 donors, 38% were extended criteria donors. Grafts were preserved in cold storage (64%) or machine perfusion (36%) with a mean cold ischemia time (CIT) of 740 minutes. At 3 months, 490 AEs (41 serious) were reported, including two graft losses and two acute rejections (3.4%). No immunological, allergic, or prothrombotic effects were reported. Preimplantation and 3-month biopsies did not show thrombosis or altered microcirculation. Secondary efficacy end points showed less delayed graft function (DGF) and better renal function in the M101 group than in the contralateral kidneys. In the subgroup of grafts preserved in cold storage, Kaplan-Meier survival and Cox regression analysis showed beneficial effects on DGF independent of CIT (P = .048). This study confirms that M101 is safe and shows promising efficacy data.

中文翻译:

首次在人体中使用海洋氧气载体 (M101) 进行器官保存:一项安全性和原理验证研究。

医疗器械M101是一种具有高携氧能力的细胞外血红蛋白。临床前研究表明其作为器官保存液添加剂的安全性及其对缺血/再灌注损伤的有益作用。用于器官保存的氧载体 (OXYOP) 是一项多中心开放标签研究,首次评估将 M101 添加 (1 g/L) 到来自同一供体的两个肾脏之一的保存液中的安全性。所有不良事件 (AE) 均由独立的数据和安全监测委员会进行分析。在 58 位捐助者中,38% 是扩展标准捐助者。移植物保存在冷藏 (64%) 或机器灌注 (36%) 中,平均冷缺血时间 (CIT) 为 740 分钟。3 个月时,报告了 490 起 AE(41 起严重),包括两次移植物丢失和两次急性排斥反应 (3.4%)。没有报告免疫学、过敏或血栓形成前的影响。植入前和 3 个月的活检未显示血栓形成或微循环改变。次要疗效终点显示,与对侧肾脏相比,M101 组的延迟移植物功能 (DGF) 更少,肾功能更好。在冷藏保存的移植物亚组中,Kaplan-Meier 生存和 Cox 回归分析显示对 DGF 的有益影响与 CIT 无关 (P = .048)。这项研究证实 M101 是安全的,并显示出有前途的疗效数据。在冷藏保存的移植物亚组中,Kaplan-Meier 生存和 Cox 回归分析显示对 DGF 的有益影响与 CIT 无关 (P = .048)。这项研究证实 M101 是安全的,并显示出有前途的疗效数据。在冷藏保存的移植物亚组中,Kaplan-Meier 生存和 Cox 回归分析显示对 DGF 的有益影响与 CIT 无关 (P = .048)。这项研究证实 M101 是安全的,并显示出有前途的疗效数据。
更新日期:2020-02-03
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