Lung Preservation for Lung Transplant

Overseen By Jessica Cobb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Re-transplantation, Multi-organ transplantation

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for preserving donor lungs overnight before transplantation. The goal is to determine if storing lungs at a specific cool temperature in a special refrigerator can make the transplant process more flexible and possibly improve outcomes. The researchers seek individuals scheduled for their first lung transplant, with no need for additional organ transplants. This study may be ideal for those whose lung transplant procedures must occur in the early morning, based on donor lung availability. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance lung transplant success.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this lung preservation method is safe for transplantation?

Research has shown that keeping donor lungs at 10°C (50°F) is a promising method. Studies have found that lungs stored at this temperature experience less damage and function better after transplant compared to those kept on ice. This approach can safely extend the preservation time before transplant.

One study discovered that storing lungs at 10°C for up to 24 hours did not negatively affect short-term or medium-term outcomes after transplant. Patients who received these lungs did well both shortly after their surgeries and some time later.

Overall, storing lungs at 10°C could provide a safer way to manage lung transplants by allowing more time without harming lung function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new lung preservation technique that could improve lung transplant outcomes. Unlike the traditional method that involves transporting donor lungs solely on ice, this trial examines maintaining lungs at a controlled temperature of 10°C after initial transportation in a cooler. This approach aims to extend the preservation time and potentially enhance the condition of the lungs upon transplantation. By refining how donor lungs are preserved, the trial could lead to more successful transplants and better patient outcomes.

What evidence suggests that preserving donor lungs at 10°C could be effective for lung transplants?

In this trial, donor lungs will be preserved using cold static preservation at 10°C, a method research has shown to safely extend preservation time. Studies have found that lungs stored at this temperature can last up to 24 hours without affecting transplant success. This method reduces lung damage, maintaining them in good condition for surgery. In five cases, lungs stored at this temperature for 10 to 16 hours were successfully transplanted, demonstrating the effectiveness of this approach. This preservation technique could make the transplant process more flexible and efficient. ^{6 7 8 9 10}

Who Is on the Research Team?

Mindaugas Rackauskas, MD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for patients who need a lung transplant and have given informed consent. It's open to those receiving their first lung transplant from donors under 70 years old. However, it excludes anyone needing multiple organ transplants or re-transplantation, as well as cases where the donor is over 70 or there are concerns with how the lungs are preserved.

Inclusion Criteria

I am a donor under 70 years old.

I have had a lung transplant.

Informed consent provided

Exclusion Criteria

I am not older than 70 years.

I am interested in treatments that save my organs.

I am undergoing or have undergone an organ transplant again.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation Procedure

Transplant procedure with lungs preserved at 10C cold static preservation. The procedure is scheduled to start between 6:00-8:00am if donor cross clamp time is between 6pm and 4am.

12 hours

Follow-up

Participants are monitored for safety and effectiveness after the transplantation procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Preserving of Donor Lungs

Trial Overview

The study tests a method of preserving donor lungs when they're available overnight (between 6pm-4am). The procedure can be delayed until after 6am using cold static preservation at our hospital for up to 12 hours between removal from the donor and starting anesthesia on the recipient.

How Is the Trial Designed?

Group I: Interventional arm Experimental Treatment 1 Intervention

During our study period, transplants with a planned recipient anesthesia starting time between 10:00pm-6:00am will be allowed to move to a 6:00-8:00am start at the earliest. To be eligible, donor lungs cross clamp time have to occur between 6pm and 4am and lungs need to be suitable for transplantation without the need for ex vivo lung evaluation. Lungs meeting criteria for direct transplantation will be transported in the usual fashion in a cooler of ice at 4oC and upon arrival to Shands UF Health they will immediately be transferred to cold static preservation at 10oC within a specific refrigerator placed in the Shands UF Health OR. The maximum preservation time from donor cold flush (cross clamp) to recipient anesthesia start should be 12 hours and the recipient procedure should not start before 6am.

Group II: Retrospective arm Active Control 1 Intervention

Outcomes will be compared to conventional transplant patients matched by age, medical diagnosis, BMI, lung allocation score and donor type ( DCD vs. NDD) using a 1:2 matching.

Preserving of Donor Lungs is already approved in United States, European Union for the following indications:

Approved in United States as Static Cold Storage (SCS) at 10°C for:

• Lung transplantation for various lung diseases

Approved in European Union as Cold Static Preservation at 10°C for:

• Lung transplantation for various lung diseases

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Preserving donor lungs at 10°C may significantly extend the cold ischemia time, which is crucial for successful lung transplants, potentially improving transplant logistics.

The report discusses two lung transplants from different donors using this innovative preservation method, suggesting that 10°C storage leads to excellent outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor lungs cold preservation at 10 °C offers a potential logistic advantage in lung transplantation. Gil Barturen, M., Laporta Hernández, R., Romero Berrocal, A., et al.[2023]

Combining cold static preservation (CSP) at 10°C with cycles of normothermic ex vivo lung perfusion (EVLP) allows for successful lung preservation for up to 3 days, leading to stable lung function post-transplant, as shown in a study with Yorkshire pigs.

In contrast, lungs preserved solely by continuous CSP at 10°C for 72 hours failed, highlighting the critical role of EVLP in revitalizing lung tissues and improving transplant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful 3-day lung preservation using a cyclic normothermic ex vivo lung perfusion strategy. Ali, A., Nykanen, AI., Beroncal, E., et al.[2022]

In a study involving 18 pigs, lungs preserved solely by hypothermic storage for 18 hours showed functional recovery comparable to sham-operated controls, indicating effective preservation without the need for flushing.

Lungs that were only cooled (hypothermia alone) outperformed those that were flushed with preservation solution, suggesting that hypothermic storage may be a superior method for lung preservation in transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothermic storage alone in lung preservation for transplantation: a metabolic, light microscopic, and functional analysis after 18 hours of preservation. Müller, C., Hoffmann, H., Bittmann, I., et al.[2019]

Ex-vivo lung perfusion is gaining acceptance as a method to extend the travel distance for donor lungs and reassess marginal donor lungs, potentially improving transplant outcomes.

Research is underway to evaluate the effectiveness of normothermic regional perfusion and to reassess the optimal temperature for static cold storage, with preliminary studies suggesting that warmer storage temperatures may allow for overnight lung storage before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung preservation: from perfusion to temperature. Bromberger, B., Brzezinski, M., Kukreja, J.[2023]

The portable Organ Care System (OCS) Lung device was successfully used to preserve and transport donor lungs in a study involving 12 lung transplant patients, demonstrating its potential for safe organ preservation.

All patients and grafts survived for at least 30 days post-transplant, indicating that the OCS Lung can effectively support high-risk lung transplants, paving the way for further comparative studies against standard preservation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normothermic perfusion of donor lungs for preservation and assessment with the Organ Care System Lung before bilateral transplantation: a pilot study of 12 patients. Warnecke, G., Moradiellos, J., Tudorache, I., et al.[2022]

The study demonstrated that continuous perfusion of lungs during cold storage significantly reduces ischemic damage compared to traditional cold storage, as shown by fewer ischemic alterations in histopathological examinations of the lungs from rabbits.

Lungs preserved with continuous perfusion maintained better oxygen levels during auto-transplantation, suggesting that this technique may enhance lung preservation and function compared to standard cold storage methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung transplantation by continuous perfusion in an experimental auto-transplant animal model. Divisi, D., Montagna, P., Jegaden, O., et al.[2013]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38320127/

Extension of Cold Static Donor Lung Preservation at 10°C

Extension of cold static preservation times at 10°C appears to be safe and has the potential to improve transplantation logistics and performance.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11888839/

Prolonged Preservation of up to 24 Hours at 10 °C Does Not ...

Prolonged static preservation of donor lungs at 10 °C for up to 24 hours is safe and does not impair short-intermediate outcomes after lung transplantation.

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frontierspartnerships.org

frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12310/full

The Advent of Semi-Elective Lung Transplantation ...

Data from large animal experiments demonstrated that organs stored at 10°C experience less mitochondrial damage. Thus, prolonged cold ischemic times can be ...

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science.org

science.org/doi/10.1126/scitranslmed.abf7601

Static lung storage at 10°C maintains mitochondrial health ...

Human lungs stored at 10°C were successfully transplanted into five patients after storage times of about 10 to 16 hours, supporting the clinical utility of ...

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Prolonged Preservation of up to 24 Hours at 10 °C Does ...

Prolonged static preservation of donor lungs at 10 °C for up to 24 hours is safe and does not impair short-intermediate outcomes after lung transplantation.

6.

jhltonline.org

jhltonline.org/article/S1053-2498(24)00077-9/fulltext

Prolonged Donor Lung Preservation of Up to 24h Using ...

Prolonged static preservation of donor lungs at 10°C for up to 24 hours seems safe and does not impair short-intermediate outcomes after lung transplantation.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38644153/

Donor Lung Preservation at 10°C: Clinical and Logistical ...

Cold static donor lung preservation at 10°C appears to be a promising method to safely extend the cold ischemic time (CIT) and improve lung transplant (LTx) ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0300289624000814

Donor Lung Preservation at 10 °C: Clinical and Logistical ...

The results showed that lungs stored at 10 °C had less injury and improved pulmonary function compared to those stored on ice. Based on these findings, the ...

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archbronconeumol.org

archbronconeumol.org/en-overcoming-limits-lung-transplantation-10c-articulo-S0300289622006305

Overcoming the Limits of Lung Transplantation: 10°C Static ...

The ideal temperature for static cold storage is 10°C, allowing longer and safer lung preservation, overcoming little by little the limits of lung ...

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jhltopen.org

jhltopen.org/article/S2950-1334(25)00036-9/fulltext

One-year clinical outcomes of an observational study ...

Studies have suggested that an extended static preservation of donor lung allografts at 10°C may offer similar clinical outcomes with the added benefits of ...