University College London

A special inquiry concluded that University College London provided some experimental implants to a now-disgraced surgeon, leading to a handful of deaths, according to a report released Sept 29.

The wide-spanning look into the regenerative medicine research at UCL had a particular focus: its ties to Paolo Macchiarini and his work at the Karolinska Institute in Sweden.

Some of the biological materials were supplied from UCL personnel – and that should not have happened, according to the investigatory report.

“We deeply regret that materials (known as POSS-PCU constructs) that had not undergone rigorous pre-clinical assessment and which were not made to GMP standards, were manufactured and supplied by Professor Alexander Seifalian’s research laboratory for direct clinical use,” the school writes, in response to the lengthy report.

“Our governance systems should have prevented that. We also regret the wider-negative impact that this work had on the field of regenerative medicine research,” they add.

The UCL-suppled materials included an artificial trachea and a graft for an artery.

Macchiarini and his work was the main focus of the investigation. The Italian-born surgeon had first reached prominence with the transplant of a cadaver trachea into a Spanish woman’s throat, using the patient’s own stem cells to prevent rejection, in 2008. Macchiarini parlayed his notoriety into a job at the prestigious Karolinska Institute in 2010. Headlines and acclaim followed.

However, a series of his patients died after the procedures involving trachea implantations. As the death toll increased, Macchiarini’s work became scrutinized for claims of fraud.

The UCL investigation focused on the ties to Macchiarini, who was named an honorary professor at the school. The plastic scaffold used in one operation by Macchiarini was constructed by Seifalian, as was a blood vessel graft used for another procedure, according to the report. The latter patient died, though the first one’s ultimate outcome remains unclear.

Seifalian was dismissed last year due to unrelated financial accusations – though he does still face two research misconduct investigations.

Seifalian told various media outlets since the release of the report last week that he was being made into a “scapegoat” for school-supported work.

The inquiry recommended that UCL further codify its approval of experimental, life-saving treatments beyond the ad-hoc “three wise men” panel of informal decision making.

“The Inquiry believes that whilst occasional compassionate use is unavoidable, the development of the field is contingent upon rigorous scientific evidence, good manufacturing practices, robust non-clinical evaluation and properly structured clinical trials,” they concluded.

Macchiarini was fired from Karolinska last year, and began a job at the Russian Science Foundation, where he was focused on the esophagus, and not the trachea. But after a retracted paper, he lost his job there, as well.