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Stem cell-based transplant trials on hold while committee investigates safety

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Science magazine reports that cellular and molecular biologist Patricia Murray, Ph.D., and biochemist Raphaël Lévy, Ph.D., of the University of Liverpool have filed a second complaint with the U.K. Parliament's Science and Technology Committee (SCT) in an effort to stop two trials of stem cell-based larynx and trachea transplants. The trials have been placed on hold while the committee investigates.

Both studies, led by University College London (UCL) laryngologist Martin Birchall, M.D., received approval from the Medicine and Healthcare Products Regulatory Agency more than two years ago and have obtained close to £5 million from U.K. funding agencies, according to the article. Dr. Birchall is a former collaborator of Paolo Macchiarini, M.D., Ph.D., a top researcher at the Karolinska Institute in Stockholm before he was fired by the institute for scientific negligence. Since then Dr. Macchiarini has been found guilty of misconduct in more than half a dozen papers and six of his eight patients have died. Swedish prosecutors are currently considering whether to reopen a criminal case against him that was closed last October, Science said.

An independent inquiry by UCL last year concluded there was no reason to cancel the trials. But last November Drs. Murray and Lévy filed the first complaint with the SCT, calling for an end to the trials. Among other things the two charged that the transplant procedure doesn’t work and isn’t safe. Additionally, they said that Dr. Birchall’s team provided inaccurate descriptions of its patients to funders and regulators, citing an application to the U.K. Medical Research Council in which the researchers stated that one of their patients "died of non-graft related causes," but in a recent case study in Stem Cells Translational Medicine, they found the death may have been the result of the transplant’s failure.

The two clinical trials placed on hold include the INSPIRE trial, a collaboration between UCL and regenerative medicine company Videregen designed to study the safety and efficacy of a transplant for patients suffering from narrowing or softening of the trachea. The second is the RegenVox trial, which would test the same procedure on patients with similar defects in the larynx.

Learn more:

http://www.sciencemag.org/news/2018/03/two-controversial-stem-cell-trials-could-harm-patients-critics-say

https://www.theguardian.com/science/2016/dec/12/leading-uk-university-launches-inquiry-into-links-with-work-of-controversial-surgeon-paolo-macchiarini

DOI: 10.1002/sctm.16-0443