Nobel laureate’s stem cell firm ‘conducted unauthorised trials’
A NOBEL laureate is embroiled in a research scandal after it emerged a stem cell company he co-founded had conducted unlawful medical trials.
Prof Sir Martin Evans, a leading geneticist and former chancellor of Cardiff university, was involved in trials in Greece described by regulators as a “violation” of national legislation. He is accused of going on to mislead a British medical watchdog when seeking approval for trials at a British hospital.
Two years after winning the Nobel Prize for his work on embryonic stem cells, Prof Evans went into business with Ajan Reginald, a struck-off dentist turned stem cell entrepreneur.
Mr Reginald was banned in 2005 after the Dental Practice Board found him guilty of mistreating patients and fleecing the board of money by claiming pay for operations he had not done.
Along with Prof Evans, he is now chief executive and co-founder of Celixir, which is sponsoring a landmark heart disease trial at London’s Royal
Brompton Hospital. The trial, which involves injecting stem cells into patients’ hearts, offers hope to millions. It was to start in 2018 but was delayed after a whistleblower alerted regulators about Celixir’s previous trial in Greece. After receiving “allegations of improprieties” about the trials, the Greek regulator found they took place “without submission of application for approval by the national competent authority and favourable opinion by the independent ethics committee”.
They said Celixir committed “serious [Good Clinical Practice] and national legislation” violations. Cardiff university is investigating an allegation that Prof Evans committed research misconduct by publishing in the Journal of
Cardiovascular Translational Research a scientific paper based on an unauthorised trial.
Celixir won approval for the UK trial after stating the cells they intended to inject into British patients had been tested in Greece in an “authorised” trial.
But after an investigation, the Health Research Authority ordered Celixir to make “substantial” changes in their brochures to ensure patients for the British trial were not misled, including references to the Greek trial, and to make clear the Royal Brompton trial was a “First in Man” study. A Cardiff university spokesman said: “We have received an allegation in relation to this. It is currently subject to a preliminary review under the university’s Academic Research Misconduct Policy. It would be inappropriate to comment further.”
A Royal Brompton spokesman said: “Our participation as a trial site in any research study is entirely contingent on receiving all necessary regulatory approvals.” Celixir declined to comment, as did Prof Evans and Mr Reginald.