Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

University of North Carolina (UNC)

Status: Terminated

Conditions: Pulmonary Fibrosis; Sarcoidosis; Bronchiectasis; Emphysema; Cystic Fibrosis; Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease (COPD); Alpha-1 Antitrypsin Deficiency

Treatments: Device: Steen Solution™; Other: Conventional Lung Transplant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01241942

UNC-001 Vitrolife

Details and patient eligibility

About

The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Lung Recipient Inclusion Criteria:

• A recipient must meet the following requirement to enroll into the study:
• Requires a single or bilateral lung transplant and is listed for lung transplant at UNC.
• Male or Female, 18 years of age or older.
• Subject or Subject's Representative provides a legally effective informed consent.
• Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
• Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria are eligible for study participation.

Lung Recipient Exclusion Criteria:

• Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

EVLP with STEEN Solution™

Experimental group

Description:

The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™.

Treatment:

Device: Steen Solution™

Conventional Lung transplant

Active Comparator group

Description:

No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.

Treatment:

Other: Conventional Lung Transplant