First-in-human use of a marine oxygen carrier (M101) for organ preservation: A safety and proof-of-principle study.
clinical research/practice
clinical trial
delayed graft function (DGF)
ischemia reperfusion injury (IRI)
kidney transplantation/nephrology
organ transplantation in general
Journal
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
ISSN: 1600-6143
Titre abrégé: Am J Transplant
Pays: United States
ID NLM: 100968638
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
01
08
2019
revised:
02
01
2020
accepted:
15
01
2020
pubmed:
6
2
2020
medline:
22
6
2021
entrez:
4
2
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 32012441
doi: 10.1111/ajt.15798
pii: S1600-6135(22)22372-7
doi:
Substances chimiques
Organ Preservation Solutions
0
Oxygen
S88TT14065
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1729-1738Informations de copyright
© 2020 The American Society of Transplantation and the American Society of Transplant Surgeons.
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