An Italian surgeon, who made headlines for pioneering synthetic trachea transplants using stem cells, is currently on trial in Sweden charged with aggravated assault on patients, in carrying out the experimental procedure.
Paolo Macchiarini (63) won praise in 2011 after claiming to have performed the world’s first synthetic trachea transplants using stem cells, while he was a surgeon at Stockholm’s Karolinska Institute.
The procedure was hailed as a breakthrough in regenerative medicine.
But allegations soon emerged that the risky procedure had been carried out on at least one person who had not been critically ill at the time of the operation.
AFP reports that he has been charged with “aggravated assault” against three patients.
The Karolinska Institute has confirmed that the three individuals have since died, but did not directly link the deaths to the operations.
Prosecutors told the court Macchiarini has carried out the surgery with “complete disregard for science and tried experience”, and referenced a review published in 2016 by physician Kjell Asplund, who argued that Macchiarini should never have been employed by Karolinska in the first place.
“It is clear that this method has not worked,” prosecutor Jim Westerberg said, adding that Macchiarini had embellished the benefits of the procedure.
Macchiarini has maintained that the operations constituted treatments, not experiments, and has denied being criminally responsible.
In 2013, the Karolinska hospital suspended all transplants and refused to extend Macchiarini’s contract as a surgeon. A year later, several surgeons at the hospital filed a complaint alleging that Macchiarini had downplayed the risks of the procedure.
He had carried out three surgeries at Karolinska University Hospital in 2011 and 2012, using an artificial windpipe made of plastic and coating it with the patient’s own stem cells. With the assistance of colleagues, he then performed a total of eight such transplants between 2011 and 2014, the five others taking place in Russia.
An external review in 2015 found Macchiarini guilty of research misconduct, but despite sacking him, the Karolinska Institute repeatedly defended him until 2018, when it found him and several other researchers guilty.
In 2018, The Lancet retracted two papers authored by Macchiarini.
The trial, held in the Solna district court near the Karolinska Institute, is scheduled to conclude on 23 May.
On 4 October 2017, MedicalBrief reported extensively on Macchiarini’s rapid rise to medical success.
He first shot to prominence in 2008 when he created a new airway for Claudia Castillo, a young woman from Barcelona; chemically stripping away the cells of a windpipe taken from a deceased donor. He then seeded the bare scaffold with stem cells taken from Castillo’s own bone marrow. Castillo was soon back home, and according to Macchiarini and his colleagues, her artificial organ was well on the way to looking and functioning liked a natural one. And because it was built from Castillo’s own cells, she didn’t need to be on any risky immunosuppressant drugs.
This was Macchiarini’s first big success and countless news stories declared it a medical breakthrough. A life-saver and a game-changer. However, the serious complications that Castillo suffered were, for a long time, kept very quiet.
By 2011, he was working at the Karolinska Institute, where he reinvented his technique. Instead of stripping the cells from donor windpipes, Macchiarini had plastic scaffolds made to order.
He gave his “regenerating” windpipes to 17 or more patients worldwide. Most are now dead.
Disgraced surgeon defends windpipe transplants at Swedish trial (Open access)
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Top UK university used overseas patients as research guinea pigs