TorEx Lung Perfusion System for Lung Transplant

Overseen By Sharaniyaa Balachandran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Re-transplantation, Multi-organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the TorEx Lung Perfusion System, which evaluates the suitability of donor lungs for transplant. By using this system, more donor lungs that might otherwise be discarded could be utilized, benefiting those waiting for a lung transplant. The trial will assess the system's safety and compare outcomes with an older method. Individuals actively waiting for their first lung transplant might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to potentially groundbreaking advancements in lung transplantation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the TorEx Lung Perfusion System is safe for lung transplantation?

Research shows that the TorEx Lung Perfusion System is a new technology, and direct safety data from its use in human lung transplants is not yet available. However, it is based on the Toronto EVLP system, which has been safely used in lung transplants since 2011. Studies have found that lungs evaluated with the Toronto EVLP system had outcomes similar to those evaluated without it, indicating it is well-tolerated. The TorEx system improves on the original by upgrading the equipment design while using the same basic method and solution, suggesting its safety might be similar. As a new system under testing, the current study aims to confirm its safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TorEx Lung Perfusion System because it offers a novel approach to assessing donor lungs for transplantation. Unlike current methods, which rely heavily on static evaluation techniques, the TorEx system uses dynamic perfusion to better mimic physiological conditions. This means it can potentially improve the assessment of lung quality and viability before transplantation, leading to better outcomes for recipients. Additionally, by optimizing the evaluation process, the TorEx system could increase the number of suitable donor lungs, helping to address the shortage of available organs.

What evidence suggests that the TorEx Lung Perfusion System is effective for lung transplantation?

Studies have shown that ex vivo lung perfusion (EVLP) is a promising method for preserving and assessing donor lungs. With EVLP, about 70% of donor lungs that might have been discarded were saved and used for transplants. The Toronto EVLP system, the first version, has been used successfully in lung transplants since 2011, with recipients experiencing similar health outcomes to those who received lungs without EVLP testing. This trial will assess the new TorEx Lung Perfusion System, an improved second version that addresses some design issues of the original. Although not yet used in human lung transplants, it is based on the successful Toronto EVLP method. ^{5 6 7 8 9}

Who Is on the Research Team?

Laura Donahoe, MD MSc FRCSC

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Recipient must provide written, informed consent

My donor lungs require a special procedure to assess their function before transplant.

I am 70 years old or younger.

Exclusion Criteria

My donor is over 70 years old.

I am receiving more than one organ transplant.

Recipient undergoing re-transplantation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Donor lungs are assessed using the TorEx Lung Perfusion System to evaluate their suitability for transplantation

Not specified

Follow-up

Participants are monitored for safety and effectiveness after receiving transplanted lungs

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TorEx Lung Perfusion System

Trial Overview 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.

How Is the Trial Designed?

Group I: Donor lungs assessed using TorEx Lung Perfusion System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12500477/

Use of Normothermic Perfusion Machines in Lung ... Ex vivo lung perfusion (EVLP) is a technique for graft preservation, evaluation and treatment, that could expand donor pool for transplantation.

2. sciencedirect.com sciencedirect.com/journal/the-journal-of-heart-and-lung-transplantation/vol/44/issue/4/suppl/S

The Journal of Heart and Lung Transplantation (16) - Outcomes of Lung Transplantation Using TorEx EVLP System. H. Yamamoto ... (18) - Normothermic Ex-Vivo Lung Perfusion Long-Term Outcomes: The NOVEL Trial.

3. jhltonline.org jhltonline.org/article/S1053-2498(24)01243-9/fulltext

CRISPR Genome Engineering in Donor Lung During ... Successful transplantation after 3-day preservation with 10°C static storage and cyclic normothermic ex vivo lung perfusion (EVLP) was shown.

4. aats.org aats.org/resources/initial-100-patient-experience-8714

Initial 100 patient experience using a next-generation ... The objective of this study is to report the initial outcomes of 100 patients transplanted using a next generation EVLP device.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6802423/

Long-term Outcomes of Lung Transplant With Ex Vivo ... In this cohort study, donor lungs treated with ex vivo lung perfusion were more injured than conventional donor lungs, but there was no difference in survival.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950925/

The impact and relevance of techniques and fluids on lung ... This review reflects on the individual technical and fluid components relevant to EVLP and their respective impact on inflammatory response and outcome.

7. ctv.veeva.com ctv.veeva.com/study/torex-lung-perfusion-system

TorEx Lung Perfusion System - ClinicalTrials.Veeva The first purpose of this study is to look at the safety of using the TorEx Lung Perfusion System in 20 consented recipients.

8. withpower.com withpower.com/trial/phase-lung-transplant-11-2022-02a6b

TorEx Lung Perfusion System for Lung Transplant 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 ...

9. researchgate.net researchgate.net/publication/391154757_Outcomes_of_Lung_Transplantation_Using_TorEx_EVLP_System

Outcomes of Lung Transplantation Using TorEx EVLP ... Conclusions: Based on these data, we observed that EVLP did not significantly impact bronchial cell vitality and airway tissue preservation nor ...