From Bench to Bedside: Technology Developed by McGowan Faculty Used in Clinical Setting
Based on core technology developed by McGowan Institute of Regenerative Medicine faculty members William Federspiel, PhD, W.K. Whiteford professor of bioengineering, chemical engineering, and critical care medicine, and the late Brack Hattler, MD, ALung Technologies developed a product called the Hemolung Respiratory Assist System (RAS) which is a dialysis-like alternative or supplement to mechanical ventilation. The Hemolung RAS was implanted into the first person in the U.S. at the University of Pittsburgh Medical Center (UPMC). The device was used as a bridge to transplantation upon receiving the U.S. Food and Drug Administration’s approval to use the technology on a compassionate use basis. The Hemolung story is a great example of moving university research from the laboratory to the market to make the world a better place and is the focus of this latest video.
The Patient’s Story
Suffering from cystic fibrosis and rejecting the transplanted lungs he had gotten just 2 years ago, Jon Sacker, 33, came to UPMC from his hometown in Moore, Oklahoma, as a last resort. But when his carbon dioxide levels spiked, making him too sick for another transplant, his family feared the worst.
“I thought I had brought my husband here to die,” said Mr. Sacker’s wife, Sallie.
Instead, UPMC clinicians turned to a Pittsburgh-made device called the Hemolung RAS that would filter out harmful carbon dioxide and provide healthy oxygen to his blood, giving Mr. Sacker a chance to gain enough strength to undergo a lifesaving transplant. He became the first person in the U.S. to be implanted with the Hemolung RAS. After 20 days on the Hemolung, his condition improved to the point that he underwent a double lung transplant and today is on the road to recovery.
“The entire series of events that led to this transplant and Jon’s recovery have been amazing,” said McGowan Institute for Regenerative Medicine faculty member Christian Bermudez, MD, chief of UPMC’s Division of Cardiothoracic Transplantation. “Jon had previously been very active and fit, and we knew we had to do whatever it took to help him.”
“Jon was in very critical condition when he came to Pittsburgh, and the Hemolung was a lifesaver for him while waiting for his second lung transplant. We are very proud of his good recovery,” said Mr. Sacker’s pulmonologist, Mario Crespo, MD, associate medical director of UPMC’s Lung Transplant Program.
The Hemolung Development Story
Several years before, Dr. Federspiel, director of the Medical Devices Laboratory at the McGowan Institute for Regenerative Medicine, along with a designer fabricator and a bioengineering doctoral student, developed what was known as the Paracorporeal Respiratory Assist Lung. The device underwent product development and was commercialized by ALung Technologies as the renamed Hemolung RAS. ALung was founded by Dr. Federspiel and UPMC’s former chief of lung transplantation, Dr. Hattler, MD.
Many patients waiting for lungs or a heart use mechanical devices as a bridge to transplant. But doctors said Mr. Sacker was too sick for the traditional extracorporeal membrane oxygenation, or ECMO. However, UPMC doctors knew about the Hemolung RAS, which removes carbon dioxide and delivers oxygen directly to the blood, allowing a patient’s lungs to rest and heal.
“We had seen the Hemolung RAS used in other countries and wanted to do whatever we could to help this patient,” said Peter M. DeComo, chairman and chief executive of ALung Technologies.
Emergency Approval for Use
Drs. Bermudez and Crespo worked with Diana Zaldonis, MPH, BSN, in UPMC’s Division of Cardiac Surgery, to request approval from the Food and Drug Administration officials to use the Hemolung RAS for this case, as no other alternative therapy was available. At this time the Hemolung RAS isn’t approved for use in the U.S. Meanwhile, Mr. DeComo drove with another ALung official in the middle of the night to Toronto, where the closest Hemolung RAS was available.
“What we do as scientists at Pitt is we develop technology. In order to get that into patients, that technology has to be translated into what’s called a product. Universities just don’t have that capability,” said Dr. Federspiel. “So I feel that a life was saved. A lot of people deserve credit for developing a safe and very effective medical device that can treat patients like Jon.”