What side effects are associated with this type of intervention?

Common treatments for lung disease, such as those used in lung transplantation and ARDS, have various side effects. Immunosuppressive drugs like Cyclosporine-A (CsA) can cause nephrotoxicity, hypertension, and increased risk of infections. Mesenchymal stem cell (MSC) therapy is generally well-tolerated but may cause transient fever and immune reactions. Inhaled nitric oxide (NO) therapy, while beneficial for oxygenation, can lead to methemoglobinemia and nitrogen dioxide toxicity. These treatments require careful monitoring to manage and mitigate potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for lung diseases, including immune checkpoint inhibitors like atezolizumab and cemiplimab for non-small cell lung cancer (NSCLC). These drugs have shown efficacy in improving overall survival and progression-free survival in patients with advanced NSCLC. Additionally, the FDA has approved tyrosine kinase inhibitors (TKIs) for EGFR-mutated NSCLC, which have demonstrated significant benefits when combined with radiotherapy. While the context does not provide specific FDA approvals directly related to lung transplantation, the focus on evaluating donor lungs for transplant suitability, as studied in the CLES trial, highlights the ongoing efforts to improve outcomes for patients with end-stage lung disease through advanced therapeutic and evaluation techniques.

What other types of research exist?

Promising, novel alternatives to CLES for evaluating donor lungs for transplant suitability include Normothermic Ex Vivo Lung Perfusion (EVLP) and the Organ Care System (OCS). These technologies allow for the assessment and preservation of donor lungs outside the body, potentially increasing the availability and quality of lungs for transplantation.

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Device

Ex Vivo Lung Perfusion for End-Stage Lung Disease

N/A

Waitlist Available

Research Sponsored by Lung Bioengineering Inc.

Eligibility Criteria Checklist

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

Must have

Patient undergoes lung transplantation

Aged 18 years or older

Must not have

Patients listed for same-side lung re-transplantation

Patients listed for multiple organ transplantation including lung and any other organ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a system called CLES. The system checks if lungs from donors, which are usually not used, can be suitable for transplanting into patients with severe lung disease. The goal is to see if using these lungs can help patients survive for a significant period or until they leave the hospital after the transplant.

Who is the study for?

This trial is for adults over 18 with severe lung disease who need a lung transplant and can give informed consent. It's not for those needing multiple organ transplants, re-transplantation of the same side lung, live donor lobar transplants, or patients with HIV or Burkholderia cenocepacia infection.

What is being tested?

The study tests the safety and effectiveness of a Centralized Lung Evaluation System (CLES) to assess potential donor lungs that are usually not used for transplantation. The goal is to see if this system helps patients survive at least six months after receiving a new lung.

What are the potential side effects?

Since this trial involves evaluating donor lungs and subsequent transplantation, potential side effects may include typical post-transplant complications such as rejection of the new organ, infections due to immunosuppression therapy, and surgical risks.

Eligibility Criteria

Inclusion Criteria

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

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You have had a lung transplant.

Exclusion Criteria

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

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You are waiting for a second lung transplant on the same side.

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You are waiting to have more than one organ, such as lung and another organ, transplanted.

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You are on the waiting list to receive a lobe of lung from a living donor for a transplant.

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You have HIV or Burkholderia cenocepacia infection.

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You have had a lung transplant without using a special procedure called EVLP, and you don't meet the requirements for matching with a subject who did have EVLP.

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EVLPExperimental Treatment2 Interventions

Group II: ControlActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Centralized Lung Evaluation System

2019

N/A

~180

Lung Transplant

2019

N/A

~180

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

Common treatments for lung disease, especially in the context of lung transplantation, include the use of immunosuppressive drugs, antibiotics, and therapies to manage ischemia-reperfusion injury. Immunosuppressive drugs, such as corticosteroids and calcineurin inhibitors, work by reducing the immune response to prevent rejection of the transplanted lung. Antibiotics are used to prevent or treat infections that can occur due to the immunosuppressed state of the patient. Therapies for ischemia-reperfusion injury, such as the use of prostacyclin analogues or PDE-5 inhibitors, help to reduce inflammation and improve blood flow to the transplanted lung. These treatments are crucial for lung disease patients as they enhance the success of lung transplants, improve survival rates, and ensure better overall outcomes.

Administration of Drugs/Gene Products to the Respiratory System: A Historical Perspective of the Use of Inert Liquids.Respiratory care in myotubular myopathy.Functional and molecular heterogeneity of pulmonary endothelial cells.

Find a Location

Who is running the clinical trial?

Lung Bioengineering Inc.Lead Sponsor

1 Previous Clinical Trials

118 Total Patients Enrolled

Media Library

Centralized Lung Evaluation System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03641677 — N/A

Lung Disease Research Study Groups: Control, EVLP

Lung Disease Clinical Trial 2023: Centralized Lung Evaluation System Highlights & Side Effects. Trial Name: NCT03641677 — N/A

Centralized Lung Evaluation System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03641677 — N/A

~26 spots leftby Sep 2025

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