JIM CARLSON/OSF SAINT FRANCIS MEDICAL CENTERHannah Warren, a 2.5-year-old girl born without a windpipe, has received a bioengineered replacement made with her own stem cells, reported The New York Times. The operation, which was carried out on April 9 at the Children’s Hospital of Illinois in Peoria, is only the sixth of its kind to be performed in the United States, and the first time the technique has been used on a child.
Warren has had a few complications but is recovering well, according to the NYT.
The scaffold and bioreactor in which the synthetic trachea was cultured with stem cells taken from bone marrow was custom-made for the patient. And although she will need a new wind pipe every few years as she grows, the researchers behind the procedure have tried to limit such replacements by including biodegradable plastic fibers to allow the trachea to stretch.
The technique has not been approved by the US Food and Drug Administration, but it was allowed to go ahead under rules permitting experimental procedures when the patient otherwise has little hope of survival.
David Warburton, director of the regenerative medicine program at the Saban Research Institute in Los Angeles, who was not involved in the work, told the NYT that “guarded optimism with a major dash of skepticism is the watchword” for experimental approaches like this. “The challenges will be making a wind pipe that functions better than a temporary fix,” he said, noting concerns about what happens to the transplants in the long term.
But Paulo Macchiarini of the Karolinska Institute in Stockholm, who led the surgery—and who has previously carried out five other bioengineered windpipe implants—told the NYT that he is now ready to proceed with an FDA-approved clinical trial in the US, which some experts in the field have been calling for.