Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure
Paul Szabolcs
Summary
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.
Description
The primary purpose of the study is to evaluate the safety and efficacy of performing lung transplantation followed by cadaveric, partially HLA-matched (≥1/6 HLA-match with an identical ABO blood type) CD3+/CD19+ depleted bone marrow transplantation in bone marrow failure and end-stage lung disease. Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fatal interstitial lung disease for which lung transplantation is the only therapy shown to prolong survival. Given the association of IPF with hematologic cytopenias and bone marrow failure, it is proposed that a tandem lung transp…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Individuals must meet all of the following criteria in order to be eligible for this study. 1. Subject must be able to understand and provide informed consent. 2. Male or female, 18 through 60 years old, inclusive, at the time of informed consent. 3. Meet criteria for UNOS listing for lung transplantation. 4. Patients must have evidence of end stage lung disease. Examples of such diseases include but are not limited to: * Pulmonary Fibrosis * COPD/Emphysema 5. Patients must have evidence of bone marrow failure with abnormal low cell count in at least one hematopoie…
Interventions
- BiologicalCD3/CD19 negative hematopoietic stem cells
Negative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation
- DrugRituximab
Transplantation Conditioning
- DrugAlemtuzumab
Transplantation Conditioning
- DrugFludarabine
Transplantation Conditioning
- DrugThiotepa
Transplantation Conditioning
- DrugG-CSF
Transplantation conditioning
- DrugHydroxyurea
Locations (2)
- UPMC PresbyterianPittsburgh, Pennsylvania
- Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania