'I might have had her for a bit longer'

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Shauna Davison: 'I might have had her for a bit longer'

Getty ImagesThe director of the Swedish Public Prosecution, Mikael Bjork, announces the reopening of a criminal negligence investigation into Paolo Macchiarini in December 2018

But, it said, there was no"deliberate fraud" or"intent to mislead" on Martin Birchall's part. Because of the"lack of intent to deceive" the university recommended education and training rather than other formal procedures. UCL told the BBC this was"reported to the inquiry by the clinicians involved in the care of Shauna Davison".

But they weren't told that Claudia Castillo's windpipe transplant collapsed just over three weeks after she'd had it and she needed stents to keep it open. One of these operations was on Kent teenager Keziah Shorten, who about two years previously had been given a tissue-engineered donor trachea by Macchiarini in Florence, after she had been diagnosed with a rare form of cancer.

The hospital added that the other patients were not discussed"because the team did not know of other relevant cases from overseas at this time". It was a treatment that hadn't been used before - after the trachea had been thawed, the donor's cells had been removed using a special vacuum technique exclusive to members of Shauna's medical team.Martin Birchall is cited as saying that Shauna's initial surgery was successful, in a letter to the European Medicines Agency

"Ciaran's trachea was not frozen beforehand whereas Shauna's was freeze-thawed and we know from papers that the group themselves have published that that would weaken the trachea... and that would make it more likely to collapse after it had been implanted," she says. The BBC asked UCL and Great Ormond Street whether the animal studies were done before or after Shauna's operation, but received no reply to this question.

Usually, researchers have to test their innovation in the lab and then on animals in preclinical research. Only then - with formal approval from a research ethics committee and the regulators - does it move into humans. But Shauna's transplant, and those of other patients, were used to obtain funding and approval for clinical trials, as well as being written about in medical journals and an application to the European Medicines Agency.

 

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