Le Meur Yannick, Badet Lionel, Essig Marie, Thierry Antoine, Büchler Matthias, Drouin Sarah, Deruelle Charles, Morelon Emmanuel, Pesteil Francis, Delpech Pierre-Olivier, Boutin Jean-Michel, Renard Felix, Barrou Benoit
Department of Nephrology, CHU de Brest, Brest, France.
UMR1227, Lymphocytes B et Autoimmunité, Université de Brest, Inserm, Labex IGO, Brest, France.
Am J Transplant. 2020 Jun;20(6):1729-1738. doi: 10.1111/ajt.15798. Epub 2020 Feb 21.
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.
医疗设备M101是一种具有高携氧能力的细胞外血红蛋白。临床前研究证明了其作为器官保存液添加剂的安全性以及对缺血/再灌注损伤的有益作用。器官保存氧载体（OXYOP）是一项多中心开放标签研究，首次评估了将M101（1克/升）添加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名供体中，38%为扩大标准供体。移植物采用冷藏（64%）或机器灌注（36%）保存，平均冷缺血时间（CIT）为740分钟。在3个月时，报告了490起不良事件（41起严重），包括两例移植物丢失和两例急性排斥反应（3.4%）。未报告免疫、过敏或促血栓形成作用。植入前和3个月时的活检未显示血栓形成或微循环改变。次要疗效终点显示，M101组的移植肾功能延迟（DGF）较少，肾功能优于对侧肾脏。在冷藏保存的移植物亚组中，Kaplan-Meier生存分析和Cox回归分析显示，对DGF有有益作用，且与CIT无关（P = 0.048）。这项研究证实M101是安全的，并显示出有前景的疗效数据。
