Closed for Enrollment

• 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.

• 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.

   

• 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.

   

• 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.

• 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.

   

   

• 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.