Artificial Lung Closer to Clinical Trial ?

Artificial Lung Closer to Clinical Trial


Clinical Trials
After nearly a decade at the drawing board, "We are looking at what we consider final design changes," Merz says. Clinical trials may get under way in one to two years. The National Institutes of Health recently granted Bartlett $4.8 million to continue the research.

Early animal studies have been promising. In the latest study, University of Texas researcher Joseph Zwischenberger, MD, tried out the BioLung on sheep whose lungs had been badly burned by inhaling smoke. Six of the eight sheep on the BioLung survived five days, whereas only one of six sheep on an external breathing machine survived that long.

Meanwhile, Bartlett has been testing the waters for future human trials. "What we wanted to do was see what the transplantation centers were thinking," he says. So he sent them a survey.

Thirty-one transplant centers completed the survey -- and those were responsible for 72% of all lung transplants in the United States in 1999. Most said they would like to see the BioLung studied in fewer than 25 animals for 30 days before beginning to test the device on humans. Almost all of them said they would support and participate in a clinical trial.

"The FDA would have the final word," Bartlett says. "This is just a start."

A one-month study on two dozen animals may seem hasty, but the situation is dire. Last year, 1,054 people received lung transplants, but 477 died on the waiting list. As of August this year, 3,797 people were still waiting to be matched to a donor.

Most of the transplant centers that responded to Bartlett's survey said the device should be tested first on people with idiopathic (meaning "of unknown cause") pulmonary fibrosis. Among the sickest of these patients, few survive longer than three months.

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http://www.webmd.com/lung/features/artificial-lung-closer-to-clinical-trial?page=2