Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts

You may not qualify if:

• Current participation in another clinical treatment trial with an investigational agent used to manage BOS before or after enrollment.
• Any condition that may interfere with the subject's ability to perform pulmonary function testing.
• Known allergy or hypersensitivity to pharmacologic agents used during ECP
• Any condition that would significantly affect the participant's ability to adhere to the protocol, affect interpretation of the study results, or put the participant at unacceptable risk for study-related complications as judged by the referring clinician. This may include a) patients with a specific acute contraindication to receiving ECP due to any acute condition such as new or evolving myocardial infarction or central nervous system disorder, hemodynamic instability or hypovolemia, acute bleeding, respiratory distress.
• Patients with lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism, or other dermatologic or ocular condition that contraindicates the use of methoxsalen or markedly enhances photosensitivity in the investigator's judgment.
• Aphakia or absence of ocular lenses
• Pregnancy (positive pregnancy test - a urine or blood pregnancy test must be obtained within 2 weeks prior to enrollment in women of childbearing potential)
• Inability to provide informed consent or to comply with study treatments or assessments (e.g. due to cognitive impairment or geographic distance)
• Recent (i.e., within 2 weeks prior to enrollment) leukopenia (white blood cell count \< 30K/cumm or 3,000/mm3/ or 3.0 109 /L)
• Patients whose decline in lung function (FEV1) is related to either Restrictive Chronic Lung Allograft Dysfunction (CLAD) or other causes that do not represent BOS such as pneumonia, heart failure, etc.
• For patients under review for eligibility for ECP for refractory BOS:
• Patients with a post-transplant baseline FEV1 \> 3 liters and most recent FEV1 \< 900 mL
• Patients with a post-transplant FEV1\< 3 liters and the most recent FEV1 \< 30% of post-transplant baseline
• Rate of FEV1 decline within the last 6 or 9 months \> 300 mL/month.
• History of receiving ECP therapy within 6 months prior to enrollment.
• +12 more criteria