Lung Transplant in Tandem with Bone Marrow Transplant for Combined Lung and Bone Marrow Failure
The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.
∙ Individuals must meet all of the following criteria in order to be eligible for this study.
• Subject must be able to understand and provide informed consent.
• Male or female, 18 through 60 years old, inclusive, at the time of informed consent.
• Meet criteria for UNOS listing for lung transplantation.
• Patients must have evidence of end stage lung disease. Examples of such diseases include but are not limited to:
‣ Pulmonary Fibrosis
⁃ COPD/Emphysema
• Patients must have evidence of bone marrow failure with abnormal low cell count in at least one hematopoietic line, making the patient a poor candidate for long-term immunosuppressive therapy. Eligible patients must meet at least one of the following criteria:
‣ Unexplained, non-drug induced neutropenia with absolute neutrophils counts of \<1500/µL the previous year, confirmed by repeat testing
⁃ Unexplained, non-drug induced thrombocytopenia with mean platelets counts of \<100,000/µL the previous year, confirmed by repeat testing
⁃ Unexplained, non-hemolytic anemia, with a hemoglobin level of \< 12 g/dL the previous year, confirmed by repeat testing
• GFR ≥45 mL/min/1.73 m2.
• AST, ALT ≤4x upper limit of normal, total bilirubin ≤ 2.5 mg/dL, normal INR, albumin \>3.0 g/dL
• Cardiac ejection fraction ≥ 40% or shortening fraction ≥26%.
• Negative pregnancy test for females, unless surgically sterilized.
⁃ All females of childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause birth defect.
⁃ Subject will also be counseled regarding the potential risks of infertility following BMT and advised to discuss sperm banking or oocyte harvesting.