The first tissue-engineered trachea implant has held up over 5 years without deterioration, immune reaction, or development of tumors, researchers reported.

The trachea recellularized with respiratory endothelium and remained open, with normal ciliary function and mucus clearance, Paolo Macchiarini, MD, of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institutet, and colleagues found.

The only problem was that the patient had a progressive scar-related stenosis in her native trachea near the junction with the new trachea that required repeated endoluminal stenting, the group reported online in The Lancet.

"These clinical results provide evidence that a tissue-engineering strategy including decellularisation of a [deceased donor] human trachea, autologous epithelial and stem-cell culture and differentiation, and cell-scaffold seeding with a bioreactor is safe and promising," the group wrote.

A similar technique was been used successfully to create a partial bladder for implantation in the 1990s.

Since the first case in 2008, other engineered tracheae have been implanted by Macchiarini's team using synthetic scaffolds coated with autologous stem cells, including one for a 2-year-old South Korean girl and one for a 36-year-old cancer patient.

The data together signal the "end of the beginning for tissue engineering," Alan J. Russell, PhD, a bioengineer at Carnegie Mellon University in Pittsburgh, wrote in an accompanying commentary.

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