What side effects are associated with this type of intervention?

The most common treatments related to Ex Vivo Lung Perfusion (EVLP), including the Toronto EVLP system and the TorEx Lung Perfusion System, generally involve the assessment and recovery of donor lungs outside the body. Known side effects of these treatments can include primary graft dysfunction, which is a form of acute lung injury occurring shortly after transplantation. Additionally, there may be an increased risk of infection, such as pneumonia, and other complications like pulmonary edema. Despite these risks, studies have shown that the outcomes of EVLP-treated lungs are comparable to those of conventionally preserved lungs.

What prior FDA approvals exist?

The FDA has not specifically approved drugs solely for Ex Vivo Lung Perfusion (EVLP) as a technique. However, EVLP itself is a significant advancement in lung transplantation, allowing for the assessment and recovery of donor lungs that might otherwise be deemed unsuitable. The Toronto EVLP system, which the TorEx Lung Perfusion System builds upon, has been integrated into clinical practice with positive outcomes. This technique involves perfusing and ventilating donor lungs outside the body to evaluate and improve their function before transplantation. While specific drugs are not the focus, the method uses perfusate solutions to maintain lung viability during the assessment.

What other types of research exist?

Promising alternatives to the TorEx Lung Perfusion System for EVLP in 2024 include the Organ Care System (OCS) Lung by TransMedics, which allows for portable, normothermic perfusion and assessment of donor lungs, and the XVIVO Perfusion System, which has been used successfully in clinical settings to improve lung preservation and evaluation. Both systems aim to enhance the viability and function of donor lungs, potentially increasing the number of suitable organs for transplantation.

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Procedure

TorEx Lung Perfusion System for Lung Transplant

N/A

Waitlist Available

Led By Laura Donahoe, MD MSc FRCSC

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of the TorEx Lung Perfusion System, which keeps donor lungs functioning outside the body to see if they can be used for transplants. It aims to help patients with severe lung disease who need transplants but face long wait times due to a shortage of suitable donor lungs. The system allows doctors to better evaluate and use more donor lungs. This modern preservation technique allows for a more accurate lung assessment and improvement in lung quality.

Who is the study for?

This trial is for individuals actively listed for a primary lung transplant, aged between 18 and 70. It's suitable if the donor lungs need extra evaluation to determine their fitness for transplantation. Candidates must consent in writing and cannot be part of another interventional trial or require multi-organ transplantation.

What is being tested?

The TorEx Lung Perfusion System is being tested on up to 20 patients to see if it's safe and effective compared to the first generation Toronto EVLP system. This new system aims to better assess donor lungs that might otherwise be discarded.

What are the potential side effects?

Since this study focuses on equipment rather than medication, side effects are related to potential complications from using assessed donor lungs in transplants, which may include typical transplant-related risks such as organ rejection or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Donor lungs assessed using TorEx Lung Perfusion SystemExperimental Treatment1 Intervention

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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

Ex Vivo Lung Perfusion (EVLP) involves maintaining donor lungs in near-physiological conditions outside the body to assess and improve their function before transplantation. The primary treatments include perfusion with a specialized solution to provide nutrients and remove waste, and ventilation to mimic breathing. These treatments help reduce lung injury, improve oxygenation, and allow for better evaluation of lung viability. The TorEx Lung Perfusion System optimizes this process by integrating all necessary equipment and controls, enhancing the ability to recover and utilize donor lungs that might otherwise be discarded. This is crucial for increasing the availability of suitable lungs for transplantation, thereby reducing wait times and improving patient outcomes.