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Bioartificial organs may ease need for donors

Trachea transplant presages a new era

THOMAS GROSSE/HARVARD BIOSCIENCE

Harvard Bioscience, of Holliston, creates a trachea for patient Christopher Lyles. The scaffold is made of nanofibers.

Christopher Lyles celebrated with a breakfast of pancakes, eggs, and bacon when he arrived home in Baltimore last week, two months after becoming the second patient ever to receive an artificial trachea, made of a plastic scaffold seeded with his own cells.

When he was diagnosed with throat cancer in early June, doctors told him surgery was his only hope for long-term survival. But conventional surgical techniques would not work because his tumor was too large for his trachea to be closed around it.

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So, Lyles, 30, opted for the experimental surgery.

The need for artificial tracheas is small, with just 1,800 trachea cancer patients a year. Eventually, though, researchers hope to be able to use the same basic technique to manufacture all sorts of “bioartificial’’ organs, from relatively simple tubes like the trachea to complex parts like the lungs, heart, and kidneys.

Harvard Bioscience Inc., the Holliston company that made Lyles’s new trachea, anticipates the bioartificial-organ transplant industry will eventually top $1 billion a year.

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The company makes bioreactors, the machines - part incubator, part rotisserie - in which the organ scaffolds are basted with cells. Until the recent trachea procedures, all of its bioreactors had been used for scientific research.

Harvard Bioscience hopes to get in on the ground floor of the nascent synthetic organ transplant industry.

“We see a very large market, because it’s a very large, unmet medical need,’’ said Harvard Bioscience’s president, David Green.

Roughly 100,000 Americans are on waiting lists for new organs, most of which come from deceased donors. The lucky ones whose bodies accept new organs will have to remain on antirejection drugs for the rest of their lives, tamping down their immune systems and making them more vulnerable to infections and other side effects.

The hope for bioartificial organs is that patients won’t have to wait for a death to receive a donated organ and won’t have to risk rejection. When the scaffold is coated with the person’s own stem cells, the body may be tricked into thinking the new organ belongs and may not mount an immune system attack.

Researchers started with the trachea because it is a fairly simple tube, shaped like a railroad tunnel with a fork at one end. It has a small surface area, and, since it carries air inside, needs only a blood supply to its exterior. Previous attempts at implanting synthetic tracheas have failed.

Surgeon Paolo Macchiarini, a professor of regenerative surgery at Karolinska Institute in Stockholm, performed the surgery on Lyles and on the first patient, a 31-year-old student from Eritrea studying in Sweden, Andemariam Teklesenbet Beyene, who had the procedure last summer. Both surgeries were done in Stockholm - though Lyles and his custom-made bioreactor are American - because the surgery has not yet been approved by the US Food and Drug Administration.

Both men are breathing well and are cancer-free, Macchiarini said.

Lyles, an electrical engineer who works for the Department of Defense, said he still gets tired, especially walking up stairs. And “don’t make me laugh too much, because it hurts a little bit,’’ he said this month from Stockholm, where he was recovering.

Dr. Harald C. Ott, an instructor in surgery at Massachusetts General Hospital and Harvard Medical School, said he expects the attention Macchiarini’s surgeries are attracting to help bring more money and enthusiasm to the biosynthetic transplant field.

But he would have liked to have seen more lab research before Macchiarini operated on the two men.

“Time will tell what the longevity of these devices is, how long they last,’’ Ott said. “I definitely hope the best for these patients.’’

Ott is concerned with how the artificial material will be integrated into the men’s bodies and how it will hold up, exposed to both the biology of the body and the outside air that passes through the trachea.

Lyles said he understood the risk he took.

He was afraid he might die when a bad case of pneumonia sent him into intensive care for a week after the surgery. He has been anxious about paying for the $450,000 surgery - a cost insurance will not cover because the procedure is experimental. (His family gave him a “nice down payment,’’ and he is trying to raise most of the rest through donations, via a transplant fund-raising group called HelpHOPELive.)

But most of all, he said, he was worried about not being alive to raise his daughter.

“That’s the whole reason I’m doing this,’’ Lyles said, shortly before returning home from Sweden. “I’ve got a 4-year-old who misses me.’’

Karen Weintraub can be reached at Karen@KarenWeintraub.com.
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