Advancing Transplantation Technologies: Bridge to HOPE Trial Reveals Promising Results with Hypothermic Oxygenated Perfusion
Thursday, July 13, 2023
Bridge to Life Ltd. recently announced the results from an interim analysis of its liver clinical trial at the 2023 American Transplant Congress (ATC). The trial, called the Bridge to HOPE Trial, is investigating the safety and efficacy of static cold storage (SCS) compared to SCS followed by hypothermic oxygenated perfusion (HOPE) using the VitaSmart™ Liver Machine Perfusion System. The trial has received approval from the U.S. Food and Drug Administration (FDA) under an investigational device exemption (IDE).
The interim analysis included data from 170 patients who underwent liver transplantation. The results showed that the HOPE arm had a lower rate of early allograft dysfunction (EAD) at 19% compared to 39% in the SCS arm. This finding is considered statistically significant and serves as the primary endpoint for the trial.
- Other positive outcomes were observed in the HOPE arm compared to the SCS arm:
- Liver graft survival at 6 months was 100% in the HOPE arm, whereas the SCS arm achieved 91% survival.
- The median hospital stay for patients in the HOPE arm was 9.5 days, while it was 11.4 days for the SCS arm.
- Biopsy-proven liver rejection at 6 months was lower in the HOPE arm (10%) compared to the SCS arm (18%).
- Among livers donated after circulatory death (DCD), those treated with HOPE had a lower incidence of ischemic cholangiopathy compared to SCS (5% vs. 14%). Additionally, there were fewer cases requiring re-transplantation in the HOPE arm (one case) compared to the SCS arm (three cases).
No serious adverse events related to the device were reported during the trial, indicating the safety of the VitaSmart™ Liver Machine Perfusion System. These findings suggest that HOPE may offer advantages over SCS in terms of early allograft dysfunction, graft survival, hospital stay, rejection rates, and outcomes for DCD livers. However, it's important to note that these results are from an interim analysis, and further data collection and analysis are necessary to confirm the long-term safety and efficacy of the HOPE approach.