The patient, implanted 2 years ago with a trachea grown using HART’s bioreactor technology, was participating in a clinical trial in Russia, according to a press release. HART said it learned of the death from the study’s principal investigator.
"The patient survived more than 2 years from the initial regenerated trachea transplant surgery that took place in 2012," HART said. "Prior to that surgery, the patient had suffered several instances of life-threatening respiratory failure and infections. The patient was indicated for the initial transplant surgery because there was both a progression of the respiratory failure and traditional tracheal surgery was impossible."
Other patients implanted with the artificial trachea, grown using a patients own cells which are seeded onto a porous plastic scaffold, have fared much better. It’s been 6 years since the 1st patient, Claudia Castillo, was implanted with an artificial trachea; last year a follow-up study published this month in the journal The Lancet revealed that Castillo was "living normally without any complications or rejection of the implanted airway" 5 years on.
Last month HART CEO David Green told MassDevice.com that news of the Castillo procedure prompted him to get in on the game. HART predecessor Harvard Bioscience eventually launched a commercial version of the bioreactor researchers used to grow the bronchus.
"Typically, the old trachea is narrowed, so the patient’s having difficulty breathing. Usually, that’s because there’s a tumor, like a trachea cancer growing in the throat, or because there’s tracheal stenosis, which means a narrowing of the trachea caused by some kind of physical damage," Green told us. "Typically, it starts with a road accident, and that’s what leads to the physical damage of the trachea. One of those 2 things, either physical damage or a trachea cancer, is what causes the patient to need this kind of transplant."