Bridge to Life Ltd., a leading global supplier of organ preservation solutions and organ perfusion technologies, announced first enrollment and orthotopic liver transplantation in its U.S. pivotal Bridge to HOPE Liver Clinical Trial (NCT05045794).
The Bridge to HOPE trial is evaluating the clinical safety and efficacy of static cold storage, the current standard for ex-vivo organ preservation, compared to cold storage followed by hypothermic oxygenated perfusion (HOPE) with the VitaSmart™ Liver Machine Perfusion System. The first transplant recipient was enrolled at Henry Ford Transplant Institute, Henry Ford Hospital in Detroit, MI. The trial is anticipated to enroll up to 244 patients undergoing transplantation at up to 15 hospitals over the next 2 years.
“I am so incredibly proud of our team here at Henry Ford for the hard work they put forth to make this clinical trial a reality” said Michael Rizzari, MD, Transplant Surgeon and site Principal Investigator. “We are very grateful for the partnership we have established with the Bridge to Life team. Their guidance has been invaluable in getting the study off the ground and we are looking forward to continued collaboration with them in the future. Most importantly, we are excited to experience first-hand the benefits that this technology can bring to our patients as well as the potential for increasing the organ donor pool.”
The first study recipient received a donor liver perfused using the VitaSmart™ Liver Machine Perfusion System. “As a surgeon, I felt this pump had a great advantage of being easy to use while providing a great alternative to static cold storage” said Tayseer M. Shamaa, MD, General Surgery Research Resident and Sub-Investigator operating the VitaSmart™ Liver Machine Perfusion System. “The VitaSmart was a quick set up and required a relatively small team to operate. These features should allow its widespread use amongst transplant centers across the country.”
“We celebrate this pivotal study milestone, thrilled with how well the inaugural Bridge to HOPE perfusion went. I salute my talented colleagues at Henry Ford and the dedicated professionals at Bridge to Life. We anticipate a rapid pace of enrolments at the various study sites – among the top tier of US transplant centers. We wish this recipient continued healthy recovery, and are grateful to the organ donor.”, said David J. Reich, MD, Professor of Surgery at Drexel University and lead investigator for the Bridge to HOPE Liver Clinical Trial.
“While the VitaSmart device and the HOPE protocol have been successful for organ transplantation in Europe and other parts of the world, the Henry Ford transplant today is an important first step to bring this device into the U.S. Hypothermic transplant using the vital component of highly concentrated oxygen is now being proven on our side of the Atlantic, case by case. Medical efficacy, combined with its ease of use, makes the HOPE procedure with VitaSmart widely accessible to hospitals because it fits easily into their logistical and cost models. This is how hospitals will want to perform transplants in the future.” said Richard Birch, VP of Business Development.
Bridge to Life is a 2022 Advocate Level Corporate Partner of The Alliance.