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Functioning Lung Transport System in Clinical Trial

Organ Care System (TransMedics Inc.)

Organ Care System (TransMedics Inc.)

A system for transporting functioning human lungs for transplants is being tested in a clinical trial, with the first transplant surgery in the U.S. occuring earlier this month. The Organ Care System tested in the trial is developed by TransMedics Inc. in Andover, Massachusetts, with the first U.S. transplant taking place at the UCLA medical center in Los Angeles.

The Organ Care System is an insulated container that pumps oxygen, nutrients, and donor’s warm blood to the organ inside, in this case human lungs. A sterile module inside the container maintains the appropriate temperature and humidity, yet still be monitored by ultrasound and blood sampling. A wireless monitor displays system functions, as well as information for physicians to assess the state of the organ.

The clinical trial tests the Organ Care System against current cold flush transport and storage methods. The study measures patient and transplant survival after 30 days, as well as adverse effects after 72 hours. Early results from the first 12 patients with the Organ Care System were reported last month in the journal The Lancet (paid subscription required), showing the system worked successfully in all 12 patients, who recovered and were discharged from the hospital.

UCLA’s Abbas Ardehali, professor of cardiothoracic surgery, is the principal investigator for the UCLA site of the trial. Ardehali says lungs are difficult to transport because they can be easily damaged. “The cold storage method does not allow for reconditioning of the lungs before transplantation,” adds Ardehali, “but this promising ‘breathing lung’ technology enables us to potentially improve the function of the donor lungs before they are placed in the recipient.”

Patients in the clinical trial are adults needing double-lung transplants, with a goal of enrolling 264 patients. The study is now recruiting patients at sites in Belgium, Germany, France, Italy, and Spain. Other planned sites in France and the U.K. have not yet started recruiting.

In the following video, Ardehali tells more about the Organ Care System and the trial.

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