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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the TorEx Lung Perfusion System treatment for lung transplant?

Ex vivo lung perfusion (EVLP) systems, like the TorEx Lung Perfusion System, have been shown to increase the number of patients treated with lung transplants by allowing evaluation and reconditioning of donor lungs that might otherwise be rejected. Studies have demonstrated that using EVLP can improve the function of marginal lungs and expand the donor pool, leading to successful lung transplants. ^{1 2 3 4 5}

How does the TorEx Lung Perfusion System treatment differ from other treatments for lung transplant?

The TorEx Lung Perfusion System is unique because it involves ex vivo lung perfusion, which allows donor lungs to be assessed and potentially reconditioned outside the body before transplantation. This method can expand the donor pool by making it possible to evaluate and use lungs that might otherwise be considered unsuitable for transplant. ^{1 2 6 7 8}

Research Team

Laura Donahoe, MD MSc FRCSC

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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 between 18 and 80 years old.

Exclusion Criteria

My donor is over 70 years old.

I am receiving more than one organ transplant.

Recipient undergoing re-transplantation

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of extracellular-type-Kyoto solution and Perfadex as a preservation solution in a pig ex vivo lung perfusion model: impact of potassium level. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Updates in lung transplantation. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of cold or warm ischemia and ex-vivo lung perfusion on the release of damage associated molecular patterns and inflammatory cytokines in experimental lung transplantation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transplantation of initially rejected donor lungs after ex vivo lung perfusion. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Utilization of the organ care system for bilateral lung transplantation: preliminary results of a comparative study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safe pulmonary preservation for 12 hours with low-potassium-dextran solution. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

EVLP: Ready for Prime Time? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The role of ex-situ perfusion for thoracic organs. [2023]