Using plastic fibers and human cells, doctors have built and implanted a windpipe in a 2 ½-year-old girl — the youngest person ever to receive a bioengineered organ.
The surgery, which took place on April 9 here at Children’s Hospital of Illinois and will be formally announced Tuesday, is only the sixth of its kind and the first to be performed in the United States. It was approved by the Food and Drug Administration under rules that allow experimental procedures when otherwise the patient has little hope of survival.
Dr. Paolo Macchiarini, a specialist in the field of regenerative medicine who developed the windpipe and led the complex nine-hour operation, said the treatment of the Korean-Canadian toddler, Hannah Warren, made him realize that this approach to building organs may work best with children, by harnessing their natural ability to grow and heal.
“Hannah’s transplant has completely changed my thinking about regenerative medicine,” said Dr. Macchiarini, a surgeon at the Karolinska Institute in Stockholm. He said he would like to proceed with a clinical trial in the United States, something that critics of his approach have called for.
Hannah was born without a windpipe, or trachea — an extremely rare condition that is eventually fatal in 99 percent of cases — and had lived since birth in a newborn intensive care unit in a Korean hospital, breathing through a tube inserted in her mouth. Because of other developmental problems, she cannot eat normally and cannot speak.
Nearly three weeks after the surgery, the girl is acting playfully with her doctors and nurses, at one point smiling and waving goodbye to a group of visitors. Dr. Mark Holterman, a pediatric surgeon at the hospital, said that Hannah was breathing largely on her own, although through a hole in her neck, not through her mouth yet. “She’s doing well,” he said. “She had some complications from the surgery, but the trachea itself is doing great.”