Since 2008, eight patients have been given a new chance at life when surgeons replaced their badly damaged tracheas with man-made versions. This highly experimental technology is now moving from research labs to a manufacturing facility as a Boston-area company prepares to produce the scaffolds for growing the synthetic organs on a large scale.
Harvard Apparatus Regenerative Technology , or HART, is testing its synthetic trachea system in Russia and has plans for similar tests in the European Union this year. The company is working with the U.S. Food and Drug Administration to set up a trial in the United States as well.
The synthetic windpipes are made by growing a patient’s own stem cells on a lab-made scaffold. In the future, this technique could be adapted to create other organs, such as a replacement esophagus, heart valve, or kidney.
If expanded into more body parts, the synthetic organ technology could help meet a dire medical need. Transplant waiting lists for vital organs such as hearts, lungs, livers, and kidneys are distressingly long. Every day, patients die waiting for donor organs. In the U.S. alone, 120,000 people are on waiting lists for an organ, estimates the U.S. Department of Health and Human Services . And waiting lists underestimate the true need, says Joseph Vacanti , a surgeon-scientist at Massachusetts General Hospital and a leader in tissue-engineering research. “The only way we are going to meet that real need is to manufacture living organs,” says Vacanti, who is not affiliated with HART.