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Multicenter Study
. 2020 Jun;20(6):1729-1738.
doi: 10.1111/ajt.15798. Epub 2020 Feb 21.

First-in-human use of a marine oxygen carrier (M101) for organ preservation: A safety and proof-of-principle study

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
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Free article
Multicenter Study

First-in-human use of a marine oxygen carrier (M101) for organ preservation: A safety and proof-of-principle study

Yannick Le Meur et al. Am J Transplant. 2020 Jun.
Free article

Abstract

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.

Keywords: clinical research/practice; clinical trial; delayed graft function (DGF); ischemia reperfusion injury (IRI); kidney transplantation/nephrology; organ transplantation in general.

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References

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