What side effects are associated with this type of intervention?

Hypothermic oxygenated machine perfusion (HOPE) is a technique used to improve the viability of liver grafts by providing oxygen at low temperatures. Common side effects associated with liver disease treatments, including HOPE, may include mild to moderate complications such as headache, nausea, and fatigue. In some cases, more severe complications like infection, bleeding, or bile duct problems can occur. Additionally, patients undergoing liver transplantation or similar procedures may experience issues related to anesthesia, such as cardiovascular instability or respiratory problems. Overall, while HOPE aims to enhance outcomes, it is essential to monitor for these potential side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for liver diseases, including antiviral medications for hepatitis C, such as sofosbuvir and simeprevir, which have shown effectiveness in improving sustained virologic response rates. For liver transplantation, static cold storage (SCS) has been a standard method for organ preservation. However, the VitaSmart Liver Machine Perfusion System is exploring the use of hypothermic oxygenated machine perfusion (HOPE) to enhance liver viability and outcomes by providing oxygen at low temperatures. This approach aims to improve upon traditional SCS by potentially reducing ischemia-reperfusion injury and improving post-transplant outcomes.

What other types of research exist?

Promising alternatives to the VitaSmart Liver Machine Perfusion System for liver disease patients include normothermic machine perfusion (NMP), which maintains the liver at body temperature and allows for real-time assessment and potential therapeutic interventions such as defatting, immunomodulation, and gene therapies. Additionally, advancements in ex-vivo liver perfusion (EVLP) systems are being explored for their potential to improve liver viability and outcomes.

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Machine Perfusion

Hypothermic Oxygenated Perfusion for Liver Transplant

N/A

Waitlist Available

Led By David Reich, MD

Research Sponsored by Bridge to Life Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)

Donor age 50-85 years

Must not have

Donor age <18 or >85 years

Anticipated cold ischemia >15 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to study participation ends at 1-year follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special machine that helps keep donated livers healthy before they are transplanted. It targets patients who need liver transplants and compares the new method to the usual way of preserving livers. The machine works by pumping cold, oxygen-rich fluid through the liver to maintain its condition. This new method has shown significant benefits in improving liver function before transplantation.

Who is the study for?

This trial is for patients needing a liver transplant, where the donor's age is between 50-85 years. The donor liver must have been preserved in cold conditions for 10-15 hours and show certain levels of fat, enzymes (ALT), and bilirubin. It excludes livers not from brain-dead donors.

What is being tested?

The study compares two ways to preserve donated livers before transplantation: traditional cold storage versus using the VitaSmart Liver Machine Perfusion System followed by hypothermic oxygenated perfusion (HOPE).

What are the potential side effects?

Potential side effects are related to how well the transplanted liver functions after surgery, which can include complications like poor organ function or rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery involves a cold ischemia time of 10-15 hours, not counting HOPE duration.

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I am between 50 and 85 years old.

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My total bilirubin level is between 2-4 mg/dl.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My donor is between 18 and 85 years old.

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My surgery is expected to have a delay over 15 hours before tissue analysis.

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My liver transplant will involve splitting the liver for use in two patients.

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My liver transplant will be from a living donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to study participation ends at 1-year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to study participation ends at 1-year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study participation ends at 1-year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration on dialysis

Length of hospital stay

Length of intensive care unit stay

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Static cold storageExperimental Treatment1 Intervention

Ex-vivo donor liver preservation using static cold storage only

Group II: Hypothermic oxygenated perfusion (HOPE)Experimental Treatment2 Interventions

Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VitaSmart Liver Machine Perfusion System

2021

N/A

~220

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for liver disease include static cold storage (SCS) and hypothermic oxygenated machine perfusion (HOPE). SCS preserves the liver by cooling it to low temperatures, which slows down metabolic processes and reduces cellular damage. HOPE further enhances this by providing oxygen to the liver at low temperatures, which helps maintain cellular function and viability. This is crucial for liver disease patients as it improves the quality and outcomes of liver transplants, potentially reducing complications and increasing the success rate of the procedure.

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