Implants Made By Scientists At Top UK University Used In Human "Guinea Pigs” Without Approval

Experimental Implants Made By Scientists At Top UK University Used In Human "Guinea Pigs” Without Approval




THE INQUIRY FOLLOWS IN THE WAKE OF THE NOW-DISGRACED SURGEON PAOLO MACCHIARINI

Scientists at one of London’s leading research institutions, University College London, have been accused of sending experimental medical implants overseas to be tested on people, despite not being approved for use in humans.

An inquiry looking into the researchers developing these experimental implants has found that they essentially treated people as “guinea pigs” and tested out novel transplant techniques that should have only been used on animals.

The inquiry came about after concerns were raised about the relationships between several researchers at UCL and the now-disgraced surgeon Paolo Macchiarini, who conducted massively unethical trials at the Karolinska Institute in Sweden. When he was working, Macchiarini became something of a celebrity, as he seemingly pioneered the use of regenerative medicine, building new airways seeded with stem cells for patients who had suffered trauma.

The surgery was hailed as a world-first and touted as a major success, with Macchiarini conducting the procedure on other patients in the following months and years. What was kept quiet were the significant and distressing complications that developed following the treatment, leading to the eventual deaths of most of the 17 patients he operated on.

In the wake of this, the university has been dragged into the situation as well. The first surgery to take place saw the trachea of a patient replaced with an artificial scaffold seeded with the patient’s own stem cells. This scaffold was built by a scientist, called Alexander Seifalian (dismissed in 2016 for an unrelated case), working at the time at UCL, but his laboratory was not actually licensed to make clinical-grade devices.

This latest inquiry has found that a whole host of other implants developed out of Seifalian’s lab were also used in patients outside of the UK, with potentially damaging consequences. One patient living in Tehran was implanted with a plastic graft that bypassed his femoral artery, which was chronically infected. This was criticized as being dangerous as the graft itself can become infected and spread the infection, requiring his lower leg to be amputated. The result of the operation has not been reported.

Another implant that was tested on a human without other trials was that of an artificial tear duct, in which surgeons implanted a tiny plastic tube into the eye of a patient in Zurich. The implant was created by an ophthalmologist undertaking a part-time PhD in Seifalian’s lab.

In his defense, Seifalain claimed that these implants were tested on humans without his knowledge, learning only of the surgery after it had taken place and assuming that those involved had received the necessary permission beforehand.

The report recommends that the cases should be reported for further investigation, but stopped short of suggesting investigations into current staff.

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