Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis
About this trial
This is an interventional treatment trial for Emphysema focused on measuring Lung Transplant, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis, Pulmonary Fibrosis, Bronchiectasis, Sarcoidosis, Pulmonary Hypertension, Alpha-1 Antitrypsin Deficiency
Eligibility Criteria
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 transplant at UNC or Duke
- Male or Female, 15 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.
Exclusion Criteria:
•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Sites / Locations
- UNC-Chapel Hill
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Ex-vivo lung perfusion (EVLP) with STEEN Solution™
Lung transplant from conventional brain-dead organ donor
The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate.
No experimental procedures will be carried out.