Long Term Results of the Use of the Oxygen Carrier M101 as an Additive to Organ Preservation Solution

Background: OXYOP was a national multicenter (six participating centers) clinical study investigating the safety and performance of the oxygen carrier M101 (HEMO 2 life[Formula: see text] used ex vivo as an additive to the preservation solution in kidney transplantation. Methods: A total of 60 consecutive grafts treated with HEMO 2 life[Formula: see text] were included between March 3rd and December 8th, 2016. Grafts were preserved either in static cold storage (standard donor) or on machine perfusion (extended criteria donor). To evaluate the safety and performance of HEMO 2 life[Formula: see text], we compared the experimental group with a control group consisting of the contralateral kidneys (the paired kidneys that did not receive HEMO 2 life[Formula: see text]. Results: This study reports the follow-up results of OXYOP patients after 48 months. We found a statistical difference in terms of patient survival at 48-month post-transplantation (98.3% with HEMO 2 life[Formula: see text] vs 86% without HEMO 2 life[Formula: see text], [Formula: see text] 0.016). Importantly, more patients in the control group were converted from calcineurin inhibitors to belatacept because of poor renal function vs none in the HEMO 2 life[Formula: see text] group. Conclusions: These results demonstrated the major benefit of HEMO 2 life[Formula: see text]in renal transplant preservation. HEMO 2 life[Formula: see text]is the first hemoglobin-based oxygen carrier whose beneficial effect in organ preservation was established after 1 year and this is confirmed at 4-year post-transplant.