Preventing ischemia/reperfusion injuries (IRIs) is a major issue in organ transplantation. At present, grafts are preserved at 4[deg]C in preservation solution in order to reduce enzymatic activity. However, the need for oxygen persists.

The medical device HEMO₂life^® is a breakthrough innovation using an extracellular hemoglobin extracted from Arenicola Marina used as an additive to organ preservation solutions. Featuring high oxygen carrying capabilities and unique anti-oxidant properties, HEMO₂life^® limits the impact of IRI with benefits for graft function and survival. Preclinical studies demonstrated its perfect safety and its beneficial effect on IRIs.

OxyOp is a multicenter open-labeled study evaluating the safety of the use of HEMO₂life^® in preservation solution (either in static or machine perfusion mode) in 58 kidney grafts. Any donor in the 6 participating centers was eligible for inclusion. HEMO₂life^® was added (1g/l) to the preservation solution only for one of the 2 kidneys (the one transplanted locally).

Grafts were preserved in static mode (64%) or machine perfusion (36%). Mean ages of donors and recipients were 50 years (18 to 89) and 51 years (21 to 72) and 23 (38%) of the donors were ECD donors. The mean cold ischemia time (CIT) was 740 min +/- 258. At 3 months, the patient survival was 100%. The number of patients with DGF (at least one dialysis session) was 14 (24.1%). No immunological, allergic or pro-thrombotic effects were reported. Analysis of the serious adverse events at 3 months found 2 graft losses, 2 acute rejections (3.4%), 4 infections (2 pyelonephritis, 1 orchitis, 1 klebsellia sepsis), 4 cardiac disorders and 11 graft complications (lymphoceles, renal dysfunctions). According to the IDSMB, these results were in line with what was expected according to the donors and recipients population. Comparison with the contralateral group (kidneys allocated elsewhere in France) showed less DGF in the HEMO₂life^® group but CIT was shorter.

In conclusion, this first study in humans confirmed that HEMO₂life^® used in preservation solution is safe and shows promising efficacy data.

CITATION INFORMATION: Le Meur Y., Morellon E., Essig M., Thierry A., Buchler M., Drouin S., Deruelle C., Badet L., Pesteil F., Delpech P-.O., Boutin J-.M., Barrou B. Evaluation of a Marine OXYgen Carrier (Hemo2Life®) for Organ Preservation: First Use in Kidney Transplantation in Humans Am J Transplant. 2017;17 (suppl 3).

« Back to 2018 American Transplant Congress