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Recruiting Phase 1, Phase 2 NCT03500731

NCT03500731 Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

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Clinical Trial Summary
NCT ID NCT03500731
Status Recruiting
Phase Phase 1, Phase 2
Sponsor Paul Szabolcs
Condition Idiopathic Pulmonary Fibrosis
Study Type INTERVENTIONAL
Enrollment 8 participants
Start Date 2018-04-19
Primary Completion 2027-12

Trial Parameters

Condition Idiopathic Pulmonary Fibrosis
Sponsor Paul Szabolcs
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 8
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2018-04-19
Completion 2027-12
Interventions
CD3/CD19 negative hematopoietic stem cellsRituximabAlemtuzumab

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Brief 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.

Eligibility Criteria

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 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, confir

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