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Experimental implants manufactured at University College London were sent abroad and used on patients despite not having approval for human use, an inquiry has found.
The implants included an artificial windpipe, a synthetic tear duct and an arterial graft.
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The inquiry, led by Stephen Wigmore of the University of Edinburgh at the request of UCL, was triggered by the university’s relationship with Paolo Macchiarini, a surgeon at the centre of a scandal in which six of eight patients who received synthetic windpipes died.
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In 2016, Macchiarini, who held an honorary professorship at UCL, was fired from the Karolinska Institute for multiple violations.
The inquiry highlighted several cases of misconduct, including that involving a 36-year-old Eritrean man living in Iceland, who had a slow growing tumour in his trachea. Macchiarini made the clinical decision to remove the tumour and replace the affected segment of trachea with a synthetic graft. This graft was provided by Alexander Seifalian, who no longer works at UCL.
Deep regret
The inquiry found that Seifalian’s laboratory was not licensed to make clinical grade devices and did not request permission to use the unlicensed devices. In a written testimony to the inquiry, Macchiarini indicated that he was not aware that the graft had not been made to clinical standard.
Seifalian welcomes the inquiry but stresses that his job was to do the basic research in the development of synthetic materials for biomedical applications. “The implantation was the job of the surgeon, who requires getting ethical approval and [regulatory] approval. This was not my job.”
“We see, time and time again, research scientists being made scapegoats for systemic problems,” he adds. “I am extremely proud of the excellent, innovative work we did at UCL and we continue to build on this to address global health challenges in a responsible and ethical manner.”
The inquiry discovered other documents that suggested plastic discs manufactured at the university but not approved for human use had been sent to Mumbai, India, where they had been implanted under the skin of a patient to test that the material was biocompatible.
An arterial graft and a synthetic tear duct also manufactured at UCL were used in operations despite not being made to accepted quality standards.
The inquiry made several recommendations to the University, including reviewing their honorary appointment process, working to improve oversight for products with clinical applications, and in assisting patients who interact with researchers.
In a statement, UCL said: “We deeply regret that materials that had not undergone rigorous preclinical assessment and which were not made to [approved] standards, were manufactured and supplied by Professor Alexander Seifalian’s research laboratory for direct clinical use. 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.”
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