A toddler who in April became the youngest person ever to receive a bioengineered organ has died, surgeons involved in her treatment said Sunday.
The girl, Hannah Warren, who was born without a trachea, died on Saturday at Children's Hospital of Illinois in Peoria, where she had undergone the experimental surgery on April 9. She would have turned 3 in August.
In the operation, Dr. Paolo Macchiarini, a specialist in the field of regenerative medicine who is affiliated with the Karolinska Institute in Stockholm, implanted a bioengineered windpipe made from plastic fibers to which the girl's own cells, taken from her bone marrow, were added. It was only the sixth surgery of its kind and the first to be performed in the United States.
But that operation had also involved surgery on the girl's esophagus, which never healed properly. She underwent another operation a month ago to correct the problem and died from complications arising from the second operation, said Dr. Mark J. Holterman, a pediatric surgeon at the hospital.
"The trachea was never a problem," Dr. Macchiarini said Sunday. "It was her native tissue that was very fragile." He said he would continue with similar operations, including one he is performing this week in Stockholm. "But all these cases are so complex and so difficult," he said.
Being born without a windpipe is an extremely rare condition that is eventually fatal in 99 percent of cases. Until this year the girl, whose father is Canadian and mother is Korean, had spent her life in a newborn intensive care unit in a Korean hospital, breathing through a tube inserted in her mouth.
The April surgery had been approved by the Food and Drug Administration under rules that allow experimental procedures when the patient otherwise has little hope of survival.
The goal of regenerative medicine, or tissue engineering, is to create or regrow tissues and organs to ease transplant shortages or treat conditions that do not have an effective cure. After years of scant progress, tissue engineers have begun to make advances as they have gained a better understanding of the role that stem cells — basic cells that can become tissue-specific ones — play in signaling the body to grow and repair itself.
Dr. Macchiarini has performed other windpipe implants similar to this one. Another patient, an American man who was operated on in Stockholm, died. An Eritrean man has lived the longest, more than two and a half years since the surgery.
After the April surgery, officials at the Peoria hospital had talked about developing plans to become a center for regenerative medicine. Dr. Holterman said it was too early to talk about what the girl's death means for those plans, although in general the feeling was that "we should get back on the horse and try again."
"Hannah was a pioneer," he said. "We knew going into this that she wasn't the best surgical candidate."
"At this point," he said, "we're all just raw with pain."
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