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BT – L-CsA – 301 – SLT: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial To Demonstrate The Efficacy And Safety Of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via The PARI Investigational EFlow® Device Plus Standard Of Care Versus Standard Of Care Alone In The Treatment Of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome In Patients Post Single Lung Transplantation
Jacksonville, FL
The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.
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A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial To Demonstrate The Efficacy And Safety Of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via The PARI Investigational EFlow® Device Plus Standard Of Care Versus Standard Of Care Alone In The Treatment Of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome In Patients Post Double Lung Transplantation (BOSTON-2)
Jacksonville, FL
The purpose of this study is to evaluate L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.
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Mesenchymal Stem Cell Therapy For Lung Rejection
Jacksonville, FL
To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS).