PMID- 32012441
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20230124
IS  - 1600-6143 (Electronic)
IS  - 1600-6135 (Linking)
VI  - 20
IP  - 6
DP  - 2020 Jun
TI  - First-in-human use of a marine oxygen carrier (M101) for organ preservation: A 
      safety and proof-of-principle study.
PG  - 1729-1738
LID - 10.1111/ajt.15798 [doi]
AB  - 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.
CI  - (c) 2020 The American Society of Transplantation and the American Society of 
      Transplant Surgeons.
FAU - Le Meur, Yannick
AU  - Le Meur Y
AUID- ORCID: 0000-0001-8913-415X
AD  - Department of Nephrology, CHU de Brest, Brest, France.
AD  - UMR1227, Lymphocytes B et Autoimmunite, Universite de Brest, Inserm, Labex IGO, 
      Brest, France.
FAU - Badet, Lionel
AU  - Badet L
AD  - Department of Urology and Transplant Surgery, Hopital Edouard-Herriot, Hospices 
      Civils de Lyon, Lyon, France.
FAU - Essig, Marie
AU  - Essig M
AD  - Department of Nephrology and Renal Transplantation, CHU de Limoges, Limoges, 
      France.
FAU - Thierry, Antoine
AU  - Thierry A
AD  - Department of Nephrology, CHU de Poitiers, Poitiers, France.
FAU - Buchler, Matthias
AU  - Buchler M
AD  - Department of Nephrology and Clinical immunology, CHU de Tours, Tours, France.
FAU - Drouin, Sarah
AU  - Drouin S
AD  - Departement D'urologie, Nephrologie et Transplantation, Sorbonne Universite, 
      Assistance Publique - Hopitaux de Paris AP-HP, Hopitaux Universitaires Pitie 
      Salpetriere - Charles Foix, Paris, France.
FAU - Deruelle, Charles
AU  - Deruelle C
AD  - Department of Urology, CHU de Brest, Brest, France.
FAU - Morelon, Emmanuel
AU  - Morelon E
AD  - Department of Transplantation, Nephrology and Clinical Immunology, Hopital 
      Edouard Herriot, Hospices Civils de Lyon, Lyon, France.
FAU - Pesteil, Francis
AU  - Pesteil F
AD  - Department of Vascular Surgery, CHU de Limoges, Limoges, France.
FAU - Delpech, Pierre-Olivier
AU  - Delpech PO
AD  - Department of Urology, CHU de Poitiers, Poitiers, France.
FAU - Boutin, Jean-Michel
AU  - Boutin JM
AD  - Department of Urology, CHU de Tours, Tours, France.
FAU - Renard, Felix
AU  - Renard F
AD  - Department of Nephrology, CHU de Brest, Brest, France.
FAU - Barrou, Benoit
AU  - Barrou B
AD  - Departement D'urologie, Nephrologie et Transplantation, Sorbonne Universite, 
      Assistance Publique - Hopitaux de Paris AP-HP, Hopitaux Universitaires Pitie 
      Salpetriere - Charles Foix, Paris, France.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200221
PL  - United States
TA  - Am J Transplant
JT  - American journal of transplantation : official journal of the American Society of 
      Transplantation and the American Society of Transplant Surgeons
JID - 100968638
RN  - 0 (Organ Preservation Solutions)
RN  - S88TT14065 (Oxygen)
SB  - IM
MH  - Graft Survival
MH  - Humans
MH  - Kidney
MH  - *Kidney Transplantation
MH  - Organ Preservation
MH  - *Organ Preservation Solutions
MH  - Oxygen
MH  - Perfusion
MH  - Tissue Donors
OTO - NOTNLM
OT  - clinical research/practice
OT  - clinical trial
OT  - delayed graft function (DGF)
OT  - ischemia reperfusion injury (IRI)
OT  - kidney transplantation/nephrology
OT  - organ transplantation in general
EDAT- 2020/02/06 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/02/04 06:00
PHST- 2019/08/01 00:00 [received]
PHST- 2020/01/02 00:00 [revised]
PHST- 2020/01/15 00:00 [accepted]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/02/04 06:00 [entrez]
AID - S1600-6135(22)22372-7 [pii]
AID - 10.1111/ajt.15798 [doi]
PST - ppublish
SO  - Am J Transplant. 2020 Jun;20(6):1729-1738. doi: 10.1111/ajt.15798. Epub 2020 Feb 
      21.