British teen Shauna Davison was given an initial transplant in 2012, in a wish of prolonging her life. Her mom says she was told in allege about dual patients who had survived a identical operation – though not about others who had died. The BBC’s Deborah Cohen asks either Shauna, who died after dual weeks, was a misadventure of a rush to arise branch dungeon technology?

Shauna Davison was innate with one lung, a split taste and a vital heart defect. But notwithstanding spending her life in and out of sanatorium she remained a happy child.

“Her illness never got her down and she always had a grin on her face,” says Shauna’s mother, Karen Davison. “Everyone was so good to her. They looked over her problems.”

When she was 12 weeks old, doctors found problems with her Trachea – or windpipe. It was unequivocally slight and when it became obstructed, she couldn’t breathe. She was given 48 hours to live.

A surgeon in Leeds came to a rescue. David Crabbe warned that it competence not work, though he managed to reconstruct Shauna’s windpipe out of her ribs.

Shauna had to stay in sanatorium for 6 months and had spherical stents put in her windpipe to keep it open.

Mr Crabbe was unequivocally caring, Karen Davison says. “The sanatorium was outstanding.”

Over a years, Shauna’s stents indispensable dilating as she grew bigger. She had a tracheostomy – an opening in a front of her neck – to assistance her breathe.

“There were times we didn’t consider she’d make it given she kept collapsing,” Karen Davison says.

---

Find out more

• This story takes about 15 mins to read
• You can also watch Deborah Cohen’s news for Newsnight on a BBC iPlayer

---

At home in Middlesbrough, she schooled how to change Shauna’s tracheostomy tube, use a ventilator, do physiotherapy to assistance her transparent her airway, suction her airway, do CPR, and give her intravenous antibiotics.

“I did all for her,” she says. “Shauna coped marvellously. But she didn’t know any different.”

An zealous Middlesbrough Football Club fan, Shauna desired wearing a football kit. She went to a mainstream school, with a support of a carer, where she could brew with other children.

“She was a impertinent child, though desired by everybody,” her mom says. “She brightened everyone’s day.”

Shauna had many operations though she’d always come through. At times, she didn’t go nearby a sanatorium for ages, Karen says.

A time came, however, when David Crabbe told her that his technique for treating Shauna was no longer going to be sufficient. Her airway was too small and they would have to demeanour for other options.

“Mr Crabbe showed me cinema of a normal airway and her airway. It was tiny,” Karen Davison says.

Shauna started to go to Great Ormond Street Hospital (GOSH) in London for tests and to have her stent changed. In 2011, doctors there told her a airway wouldn’t final many longer.

At 15, Shauna suffered a respiratory detain – a vicious occurrence in that she became incompetent to breathe – and a family was told about pioneering medicine by Prof Martin Elliott, a cardiothoracic surgeon and former medical executive of Great Ormond Street Hospital.

“They pronounced there’d been some investigate into tracheal transplants and there’d been dual other cases where it’d been done, though they couldn’t plead them with me given of studious confidentiality,” Karen Davison says. One of them was a 10-year-old boy, she adds.

“It would be a usually possibility she’d have.”

Shauna’s transplant wasn’t a compulsory one.

She would accept a donor windpipe, though it would be laced with her possess branch cells, creation it roughly like her own. She wouldn’t need drugs to stop her physique rejecting it. It was during a forefront of a new branch dungeon record – and still unequivocally experimental.

Doctors can use initial treatments if someone is terminally ill and there is no choice treatment. It’s called “compassionate use”.

Karen says she was told Shauna wouldn’t need a tracheostomy or a ventilator and she’d lead a normal life. But she was told about risks too, she adds – Shauna competence still reject a transplant, and carrying a ubiquitous analgesic is never risk-free.

Martin Elliott had formerly worked closely with a internationally eminent Martin Birchall, highbrow of ENT during University College London (UCL), on implanting a stem-cell-laced donor trachea in another child. They would work together again in Shauna’s case.

Shauna was being treated during Great Ormond Street during a time of a BBC documentary about a sanatorium in 2012. She was assessed by opposite specialists and asked what her hopes for a destiny were. Shauna told respiratory consultant Dr Martin Wallis she wanted to be means to go swimming.

It was not an easy preference to have a operation. In Martin Wallis’s words, it was not a conditions where there was zero to lose.

“They’ve got utterly a bit to lose. And this is going to make for a formidable decision,” he said. “She’s got a reasonable peculiarity of life, she’s got her good friend, she clearly has a clarity of humour and is enjoying herself – it creates it harder.”

“I wanted her to have it finished while she was good rather than wait until she was indisposed and it competence not happen,” Karen Davison says.

But given it was such an initial procedure, her medical organisation discussed it with a Great Ormond Street Hospital ethics committee.

“I don’t consider she will die if we do a procedure. We’re perplexing to do a procession so that she doesn’t. Or during slightest we lengthen her life and her peculiarity of life for as prolonged as possible,” a surgeon, Martin Elliott, tells a cabinet on camera.

“They couldn’t give me a time when she’d die though they pronounced she will die eventually. Because her airway would usually give up. So there was this procession they pronounced they were peaceful to do,” Karen Davison says. “Like any other parent, if we suspicion this was going to assistance your child live, we concluded to it.”

So in Feb 2012, Shauna was given a transplant of a donor trachea newly populated with her possess branch cells.

Initially, all seemed to go well. “For a initial integrate of days she was marvellous,” her mom recalls. “I couldn’t trust how good she recovered after it.”

Two weeks after her operation Shauna was altered from Great Ormond Street by ambulance to a sanatorium in Leeds. But during a send Shauna started to cough a lot and was in need of suction to transparent her throat.

“We suspicion that was strange, though suspicion it competence have been due to a journey,” Karen Davison says. “I usually thought, ‘Another integrate of weeks and we’ll be home.'”

But a successive morning, Shauna took a spin for a worse.

“Her chest was pulling in,” Karen says. She remembers Shauna saying, “Help me, assistance me.”

“It was a misfortune day of my life given we couldn’t assistance her.”

Shauna’s new trachea had collapsed.

“They pronounced she’d struggled that many to breathe, her heart had given up,” Karen Davison says.

“She was a smashing child. we skip her so much.”

When a initial transplant regulating a donated windpipe coated with a patient’s possess branch cells was carried out in 2008 it finished tellurian headlines.

It was suspicion that stripping a donor’s cells from a aspect of a trachea and seeding it with a patient’s possess branch cells combined a new organ that would be like a patient’s possess tissue. No anti-rejection drugs would be indispensable for a “tissue-engineered” trachea.

The operation was carried out by Italian surgeon Paolo Macchiarini with a assistance of Martin Birchall, afterwards a surgeon during Bristol University. The target was 30-year-old Claudia Castillo, who had illness in partial of her windpipe that leads to a lungs – a bronchus.

Her box was created adult in The Lancet. Five months after she’d had her operation, she was reported to be in ideal health.

Martin Birchall, who had helped to ready a donor trachea, pronounced during a time that it would “represent a outrageous step change in surgery. Surgeons can now start to see and know a intensity for adult branch cells and hankie engineering to radically urge their ability to provide patients with vicious diseases.”

Many around a universe agreed. It was a “milestone in medicine”, “unadulterated good news” and “a text instance of general collaboration”.

“It was seen as revolutionary, as rarely innovative… opening a doorway for new and sparkling tech regulating a matrimony between branch cells and synthetic scaffolds that could pierce onward this wholly new margin of regenerative medicine,” recalls Prof John Rasko, boss of a International Society for Cellular Therapy.

It had “the sniff of a Nobel Prize about it,” he says.

Indeed, shortly a university that hands out a Nobel Prize for medicine, Stockholm’s prestigious Karolinska Institute, offering Macchiarini a post. Birchall, for his part, altered to University College London (UCL), where Macchiarini was also finished an titular professor.

Claudia Castillo’s operation served as a template and shortly others had identical procedures. In 2010, Professor Birchall told a discussion “we have finished a serve 5 adults”.

Apart from Shauna, UK patients given a tissue-engineered trachea embody 19-year-old Keziah Shorten and 10-year-old Ciaran Finn-Lynch. Shauna’s surgeon, Martin Elliott, led a transplant organisation that achieved Ciaran’s operation, with a assistance of Macchiarini and Birchall.

Like Claudia Castillo, his procession was published in a medical biography and it garnered tellurian headlines. Martin Birchall told journalists: “He is left with a healthy organ there, finished from his possess branch cells, and that in a approach is a kind of miracle.”

But shortly questions started to be asked about a stem-cell-laced tracheas.

For Macchiarini, this meant his duration arise was mirrored by a fast tumble from grace. He had switched from regulating donated tracheas to cosmetic ones, also laced with branch cells. The formula were catastrophic – his patients died.

Macchiarini was investigated several times by Karolinska before he was fired. Allegations finished opposite him were primarily discharged though a sanatorium has given found him guilty of systematic bungle and many of his systematic papers have been retracted. Swedish prosecutors reopened a rapist loosening examination opposite him in Dec final year. He has formerly denied any negligence.

Bo Risberg, highbrow emeritus of medicine during a University of Gothenberg and a former authority of a Swedish Ethics Council has pronounced a events volume to a biggest investigate liaison Sweden has gifted in complicated times.

“Everything was swept underneath a carpet,” he said. Macchiarini’s disaster to do pre-clinical tests on animals regulating a cosmetic tracheas was “the misfortune crime we can commit”, he added.

One of Macchiarini’s early critics was Pierre Delaere, highbrow of ENT during University Hospital Leuven in Belgium, who has argued that it is “impossible from a fanciful indicate of view” to settle a new blood supply to a tissue-engineered trachea, either cosmetic or donated.

In 2015, he wrote to UCL casting doubt on a thought of “tracheal regeneration”, job it “the biggest distortion in medical history”. By this time Macchiarini had left UCL.

In a successive unpublished news into Delaere’s claims, seen by a BBC, UCL expel doubt on a thought that branch cells “played any healing role” in Ciaran’s operation.

But, it said, there was no “deliberate fraud” or “intent to mislead” on Martin Birchall’s part. Because of a “lack of vigilant to deceive” a university endorsed preparation and training rather than other grave procedures.

Meanwhile, a university was gearing adult to control clinical trials into stem-cell-regenerated tracheas and larynxes – called Inspire and RegenVox respectively. Martin Birchall was principal questioner with shortcoming for heading a trials. He and his organisation would pierce in millions of pounds of investigate appropriation to a university.

It wasn’t a usually time UCL constructed a news into regenerative medicine during a university. In 2017, it published a commentary of a special inquiry, set adult after a Macchiarini revelations. This found no error with Martin Birchall and privileged a approach for destiny clinical trials to proceed.

It pronounced that, when asked, Shauna’s family “were beholden for a eventuality that her daughter perceived and hold no sarcasm with a tracheal organisation during GOSH”.

UCL told a BBC this was “reported to a exploration by a clinicians concerned in a caring of Shauna Davison”.

But Shauna’s mother, Karen Davison, says nobody connected to a exploration had ever asked for her views.

The some-more we have looked into Shauna Davison’s story a some-more we have detected that Karen Davison did not know.

The dual patients Karen and Shauna listened about were a 10-year-old boy, Ciaran Finn-Lynch, and Claudia Castillo, both of whom are still alive.

But they weren’t told that Claudia Castillo’s windpipe transplant collapsed usually over 3 weeks after she’d had it and she indispensable stents to keep it open. (She’s given had to have a lung removed.)

Nor did Karen and Shauna hear about many of a other cases Martin Birchall talked about in 2010.

One of these operations was on Kent teen Keziah Shorten, who about dual years formerly had been given a tissue-engineered donor trachea by Macchiarini in Florence, after she had been diagnosed with a singular form of cancer.

But around a year after a operation, her transplant failed. Martin Birchall told a Swedish documentary in 2016 that her tissue-engineered windpipe had damaged down. When she was subsequently operated on during University College London Hospital they transposed it with a cosmetic one. She died a month before Shauna’s operation.

According to John Rasko there is a “strong requirement to give a full and straightforward comment of all a information that’s available. Exceptionalism and incompatible bad cases is unequivocally something that is not acceptable.”

A orator for GOSH said: “As a patient, Keziah’s condition and her swindle were unequivocally opposite to Shauna, so it was not clinically applicable to plead her case.”

The sanatorium combined that a other patients were not discussed “because a organisation did not know of other applicable cases from abroad during this time”.

There was some-more that Karen and Shauna did not know. They did hear about Ciaran Finn-Lynch. But there were pivotal differences between Shauna’s operation and his.

Ciaran had perceived a stent – though Shauna didn’t. According to a 2017 UCL exploration report, Martin Elliott pronounced that he had wanted to use a stent though was suggested not to.

Ciaran had also perceived a uninformed donor trachea. Shauna’s wasn’t fresh. It had been solidified and afterwards thawed.

It was a diagnosis that hadn’t been used before – after a trachea had been thawed, a donor’s cells had been private regulating a special opening technique disdainful to members of Shauna’s medical team.

Trish Murray, highbrow of branch dungeon biology and regenerative medicine during Liverpool University, has a series of criticisms.

“The existence is that if we don’t have a stent, a trachea will collapse, that’s been a unanimous knowledge of all patients who’ve gifted trachea transplantation,” she says.

“So nonetheless it’s obvious that stents means problems, if we don’t have a stent, afterwards a trachea will fall and a studious will suffocate.”

Another emanate was a solidified trachea.

For a organisation it finished ideal clarity to solidify a trachea, as a trachea could be stored adult in allege and thawed when needed. But Trish Murray is vicious of this preference too.

“Ciaran’s trachea was not solidified previously given Shauna’s was freeze-thawed and we know from papers that a organisation themselves have published that that would break a trachea… and that would make it some-more expected to fall after it had been implanted,” she says.

However, UCL questions a aptitude of these studies. It has told a BBC that they do not impute to a technique used on Shauna.

Trish Murray says other worrying studies should have stage alarm bells. She points to an unpublished investigate looking during a opening technique, that shows that one pig that perceived a transplant died casually and another grown “respiratory compromise” and had to be put down. The investigate was stopped on benevolent grounds.

“We know from information that’s been performed from FOI requests that a organisation in UCL have attempted a technique on dual pigs and both pigs died utterly quickly. We also know that they’ve attempted it on rabbits and there was 100% mankind in a rabbits as well,” she says.

The BBC asked UCL and Great Ormond Street either a animal studies were finished before or after Shauna’s operation, though perceived no respond to this question.

And like Belgian ENT highbrow Pierre Delaere, Trish Murray questions a purpose a branch cells played.

“There’s indeed no justification that any of those cells survive, in fact utterly a lot of justification that they don’t survive,” she says.

But how were doctors and scientists concerned in a caring of severely ill patients means to use these tracheas when there was small justification that they worked?

Usually, researchers have to exam their creation in a lab and afterwards on animals in preclinical research. Only afterwards – with grave capitulation from a investigate ethics cabinet and a regulators – does it pierce into humans.

Martin Birchall, however, wrote in a Lancet that “compassionate studies”, a procession for regulating new treatments on unequivocally ill patients, were “powerful ways to surprise dynamically designed grave trials” and would “expedite a contrast of novel therapies”.

“The surgeons concerned have used this apparent loophole of merciful use to indeed examination on patients and afterwards they’ve used a information that they’ve performed to go to a regulatory authorities to get accede for a trials,” Trish Murray says.

John Rasko agrees with Trish Murray that this is not how a complement should work.

“Exercising a choice of merciful use brings with it good responsibility. It shouldn’t be used as a approach that doctors can fly underneath a radar of scrupulously undertaken regulated medical practice,” he says.

And Great Ormond Street agrees too. “We do not see merciful use as a approach of contrast novel treatments,” a orator said.

But Shauna’s transplant, and those of other patients, were used to obtain appropriation and capitulation for clinical trials, as good as being created about in medical journals and an focus to a European Medicines Agency.

The BBC has found that during slightest 7 of these papers and publications falsify Shauna’s diagnosis or genocide in some way.

For example, in one 2016 focus to a European Medicines Agency, Martin Birchall is cited as observant Shauna’s initial medicine was successful though she suffered a “fatal cardiovascular eventuality 6 weeks following surgery” – given in fact she died after dual weeks, given her trachea had collapsed.

By a time a clinical hearing to exam a tissue-engineered trachea transplants was authorized and saved by open bodies, a change had been finished to a procedure. Having schooled from what happened to Shauna, a organisation would make certain patients in a hearing had a stent.

And even then, a authorized studious information sheets concomitant one of a trials contained erring information about Shauna and indeed about Claudia Castillo. Only they and Ciaran Finn-Lynch were enclosed in a information piece – notwithstanding a organisation meaningful about during slightest 10 cases worldwide.

As early as 2014, Martin Elliott had told a discussion 10 patients had perceived a tissue-engineered trachea, all of whom had died detached from Claudia and Ciaran.

Last year, a clinical trials were suspended. UCL says nobody had been recruited to participate.

Much of what a BBC has unclosed about what happened to Shauna does not seem in UCL’s special exploration report.

Leonid Schneider is a molecular-cell-biologist-turned-journalist who has been covering regenerative medicine given 2016. He was called to give justification during UCL’s exploration and is ban in his estimation of their report.

“Why didn’t Shauna’s mom have a full information? And whose thought it was not to give her a stent?” he asks.

“Finally, how could UCL investigators suggest a donor trachea clinical trials to resume, after Prof Delaere and myself told them how many people have died of it?” he adds.

UCL says that clinical caring was “beyond a range of a inquiry”.

It adds: “Any investigate undertaken during UCL is compulsory to heed to a top legal, reliable and regulatory standards, and we will not demur to take a required action, if and when this falls short.”

After receiving reliable advice, we told Karen what a BBC had found out about tissue-engineered transplants.

She was upset. She pronounced this competence have altered her preference about permitting Shauna’s operation to go ahead.

“I wish that nobody else has to go by what I’ve left through, we unequivocally do. They should be stopped. That is such a shock. People ask me, ‘How did Shauna die?’ And we always say, heart attack. I’ve never once blamed those surgeons for her death. They have a lot to comment for.”

GOSH said: “Before Shauna’s operation was carried out a extensive examination was conducted of all a applicable published systematic and medical evidence.”

They also said: “We are contemptible a diagnosis did not work for Shauna and a family feel they did not accept all applicable information. We are contacting Shauna’s family to offer to accommodate them to speak by any concerns.”

“It’s taken them all this time, though you’d consider they would have phoned me and pronounced something to me,” says Karen Davison. “I know we wouldn’t have had her forever, though during slightest we competence have had her for a bit longer.”

Photographs of Shauna Davison pleasantness of Karen Davison

Join a review – find us on Facebook, Instagram, YouTube and Twitter.