It was the case from the superstar surgeon, the prestigious Swedish institute and the ill-fated windpipe transplants that escalated into allegations of wrong doings, dismissal and a criminal investigation.
Now, a leading British university has launched an query into its own links with the endeavours of Paolo Macchiarini, the surgeon at the centre of the trachea operations subsequent which six patients died.
The surgical procedure, pioneered five years ago with the world’ s first artificial windpipe transplant at Stockholm’ s prestigious Karolinska Company, appeared to mark the beginning of an era in which artificial organs might be created from scratch by scientists and seamlessly integrated into the body.
However , the remarkable success story started to unravel. In March, the Italian surgeon was terminated from the Karolinska Institute amid an unfolding medical scandal and Swedish prosecutors are conducting a criminal analysis.
Now, in a case that has sent waves across the scientific world, University College London has released an inquiry into links with the controversial surgeon.
The latest investigation will probe its partnership with regenerative medicine research that may have taken place with Karolinska. Several of its senior scientists contributed to the treatments pioneered by Macchiarini, in which donor or synthetic tracheas were seeded with the patient’ s own stem cellular material with the aim of creating new, functioning organs.
There is no suggestion that the UCL academics are implicated in a misconduct.
The regenerative surgery at first appeared to have gone well, and was described as profitable in high profile journal articles, but it later emerged that will six of the eight patients to receive synthetic tracheas acquired died, while another remains in intensive care. Karolinska’ s vice chancellor resigned and its entire board had been sacked earlier this year after they continued to back the Italian language surgeon despite warnings of clinical and scientific wrong doings.
Karl-Henrik Grinnemo, a surgeon who proved helpful alongside Macchiarini at Karolinska, said of his previous colleague that there was always a sense of emergency that resulted in him bypassing standard ethical safeguards in international collaborations.
“ It was ‘ They’ re significantly ill and they will die very soon and… we can’ to wait to get the permissions from the regulators’, ” he stated. “ Everything was always in a hurry when it came to Paolo Macchiarini. ”
Alexander Seifalian, an ex UCL professor of biomaterials, created the first synthetic trachea to be transplanted into a patient. The 36-year old Eritrean man, Andemariam Beyene, had been suffering from advanced tracheal malignancy and died two-and-a-half years after the transplant. Seifalian has been dismissed from UCL in July, after a tribunal within an unrelated case found that he had dishonestly obtained £ 24, 000 from an overseas student.
Seifalian, who had developed a polymer material to help make artificial ears and noses, said he agreed to create a synthetic trachea in just 10 days after being approached simply by Macchiarini, who told him his patient had just two weeks to live. In a 2013 TED talk, Seifalian remembered asking his PhD student to obtain sheep and this halloween tracheas from the butchers, because they did not know what the body organ looked like.
“ I said ‘ Continue Google and type in trachea’, ” he recalled within the talk.
According to Grinnemo, who assisted within the operation, “ none of the [Stockholm] sufferers needed an operation that urgently. They would have survived actually years. You could have waited for the regulators to look at the materials and the cells. ”
Grinnemo later figured the entire synthetic trachea concept was doomed to fall short because the plastic would inevitably become infected as it had been exposed to bacteria and viruses with each breath, incorporating that he now views the synthetic transplant as a “ death tube”.
While the material was authorized as safe for clinical use, the actual trachea had been never formally assessed as a new medical device, which means this risk was not fully considered.
Seifalian told the Guardian: “ At the time he came to our own laboratory and he said this is the only chance of survival with this patient… Yes if we had a longer time, we would make a better scaffold. Everything was in a rush. ”
Seifalian later made a synthetic trachea for a 20-year-old British woman, Keziah Shorten, who was treated at University or college College Hospital London in 2011.
Matn Birchall, an UCL professor of laryngology who matched the surgery, said that on the back of positive reviews from Karolinska, the team were given approval to perform an artificial trachea transplant under compassionate use rules. The surgical treatment allowed Shorten, who had been in a critical condition in intense care following cancer treatment, to return home for a short period, but she died three months later.
“ At the time it was the rational thing to do, ” stated Birchall. “ We wouldn’ t do it again now. ”
Birchall had collaborated with Macchiarini on the transplant carried out in a Spanish clinic in 2008.
He too recalls a sense of urgency when assisting to prepare the donor trachea that had been stripped of its tissue and re-populated with stem cells taken from the bone fragments marrow of the 30-year-old patient, Claudia Castillo.
Birchall, then at Bristol University, was given permission by Human Tissue Authority to prepare the cells in a veterinary lab, that was not licensed for clinical applications. In a 08 letter the HTA said it would not stand when it comes to what “ could in this particular case be life-saving therapy” for a “ carcinoma patient”.
The particular surgery was required because one branch of Castillo’ s windpipe (the bronchus) had been damaged by a TB infection. Her left lung was at risk of being operatively removed, but she was not at immediate risk associated with dying, according to the Barcelona clinic where she was dealt with.
Birchall told the Guardian that he thought the additional risk this carried was justified because “ my firm belief was her life was in risk and we needed to move quickly”, adding that even so he’d not have carried out the work without HTA approval.
There is no suggestion that the cells caused any health problems, yet Castillo suffered extensive complications and ultimately had the girl lung removed earlier this year, raising questions about whether the danger was warranted.
In a statement, UCL stated: “ Following recent events at the Karolinska Institute within Sweden relating to some aspects of regenerative medicine research, UCL’ s Vice Provost (Research) has instigated a special query in order to establish the nature and scope of regenerative medication research at UCL and to establish the nature of UCL’ s relationship with regenerative medicine research that may took place at the Karolinska Institute. ”
Macchiarini rejected claims that he misrepresented the clinical condition associated with patients to collaborators. Of the first synthetic transplant, he or she said: “ All of us involved in Andemariam Beyene’ s treatment wanted to give him the very best chance possible, and he and his household expressed their gratitude for the extra years we offered him. ”