Paolo Macchiarini who made headlines for pioneering surgery is charged with aggravated assault over procedure.

Macchiarini has gone on trial in Sweden charged with aggravated assault, 11 years after he first performed experimental transplants of synthetic windpipes on patients. The trial centres on three transplants Macchiarini performed between 2011 and 2013, when a synthetic windpipe coated with the patient’s stem cells was surgically implanted in two men and a woman at Karolinska University Hospital in Stockholm. All three transplant recipients have died since they had the operations.

“He contends that he has performed health care, cured and helped,” Macchiarini’s lawyer Bjorn Hurtig told AFP during a recess of the ongoing trial.

The trial will be heard in Solna District Court from 27 April to 23 May. In total, 13 days are scheduled for the hearing.

It initiated a debate

The controversial trachea transplantations by the notorious surgeon Paolo Macchiarini created a storm in the scientific world during 2016. It initiated a debate on the intersection between research and healthcare and the importance of a distinct ethical compass for the patient’s safety.

At first the world was in awe about the groundbreaking news. Paolo Macchiarini, a well-renowned thoracic surgeon and guest professor at the Karolinska Institute (KI) in Stockholm, had implanted the world’s first artificial trachea. He had replaced missing or damaged windpipes with an artificial trachea made of a polymer scaffold “seeded” with the patient’s own stem cells, which were supposed to grow into living tissue. A 36-year old patient, an Eritrean man with tracheal cancer had undergone a successful transplantation and – at the time – seemed to be recovering and in good health, according to the reports that the surgeon himself gave. Two more patients underwent surgery and Paolo Macchiarini also tested the technique in Krasnodar, Russia. Macchiarini received international tributes and his transplantations of artificial trachea were perceived as pioneering. Finally there was a new possibility that had opened up that could solve the problem of the lack of donated organs. These could now be built in the laboratory and a new era of regenerative medicine could begin.

But the development took a dramatic turn, with devastating consequences.The transplants had not been as successful as had been hoped for. The artificial tracheas did not integrate with the patients’ own tissue resulting in severe complications, and tragically to lethal consequences. Most of the patients who had been treated by Macchiarini passed away some time after their operations. Colleagues at KI also alleged that Macchiarini’s papers made his transplants seem more successful than they were, omitting the serious complications. He was also criticized for persuading patients to undergo surgery, performing it without proper clinical trials in animals first and performing operations while knowing that the implants were not in a good condition.

Read more: In the name of science?