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Clinical Studies
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An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed participation to BOSTON-1 and BOSTON-2 studies (BOSTON-3)
Jacksonville, Fla.
The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.
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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 (BOSTON-1) (BOSTON-1)
Jacksonville, Fla.
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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BT – L-CsA – 302 – DLT: 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) (BOSTON-2)
Jacksonville, Fla.
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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Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
Jacksonville, Fla.
The purpose of this study is o evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)
Jacksonville, Fla.
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.
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High Throughput Screening Biomarkers for Lung Cancers (Lung Cancer Biomarkers)
Jacksonville, Fla.
The purpose of this study is to evaluate new and complementary analytical MS technologies to identify and define the metabolic biomarkers for lung cancer.
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Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.
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OCS-CAR-08242020: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP) (OCS-CAR-08242020)
Jacksonville, Fla.
The purpose of this study is to enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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The Characteristics of Adipose Derived Mesenchymal Stem Cells Obtained From The Fat Pad Surrounding The Pericardium
Jacksonville, Fla.
The purpose of this study is to collect preliminary data on the prevalence and characteristics of adipose derived mesenchymal stem cells (ADMSCs) obtained from the fat pad surrounding the pericardium and to compare ADMSCs' prevalence and characteristics with ADMSCs obtained from other parts of the body which is described historically in the literature.
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The Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in Humans and Rejection in Heart and Lung Transplant
Jacksonville, Fla.
The purpose of this retrospective and prospective study is to evaluate tissue bank from donors and recipients who underwent heart and lung transplant in order to study the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in humans and rejection.
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The VENT-AVOID Trial; A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support (VENT-AVOID)
Jacksonville, Fla.
There are currently no devices approved in the United States for providing continuous, temporary, extracorporeal carbon dioxide removal (ECCO2R). Although such devices have approvals outside of the United States, there have been no pivotal randomized, controlled trials (RCT) that have scientifically validated the safety and efficacy of ECCO2R for any potential indication. A primary potential indication is for acute hypercapnic respiratory failure in patients experiencing an acute exacerbation of COPD.
This study is being conducted under an FDA approved IDE to establish the safety and efficacy of an investigational Class III medical device for FDA pre-market approval (PMA) via a pivotal RCT to scientifically validate the indication for its use in acute exacerbation of COPD.
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