Karolinska Hospital carried out stem cell treatment without permission

The Karolinska Institute and Karolinska University Hospital conducted research on patients without proper permission between 2011 and 2016, newspaper Svenska Dagbladet reports.

At least 68 severely ill patients, including children, were treated with cultivated cells from placentas without securing a valid permit from the Health and Social Care Inspectorate.

Katarina Le Blanc, professor of clinical stem cell research at the Karolinska Institute, believes today's news could be bigger than the Macchiarini scandal.

“It is the same error in logic, but this involves a lot more patients and it has been systematically going on for years,” Le Blanc told Svenska Dagbaldet. “Unknowingly, patients have been exposed to extreme risks. You should not be allowed to do just anything only because a patient is terminally ill.”

While there was a general permit granted by the Regional Ethical Review Board, the application did not disclose the intent to mass produce the cells or how the study planned to evaluate side effects in patients.

Karlininska has already been rocked by the so-called Macchiarini scandal after star surgeon, Paolo Macchiarini, conducted a number of synthetic trachea replacements at Karolinska University Hospital without the necessary permits and under other dubious circumstances. Only two of the eight patients survived, but all with serious complications.