Comment on a news report on TV4

Commentary: According to a news feature on Swedish TV4 Monday August 22, a researcher at KI has been conducting a drug trial without permit. Karolinska Institutet considers the accusation to be inaccurate and maintains that no research has been conducted without valid permits.

A study at Karolinska Institutet and Karolinska University Hospital, where patients with scar tissue on the vocal cords have been operated with their own stem cells, has been put on hold awaiting renewal of permits. Studies involving patients injected with endogenous mesenchymal stem cells injected into the vocal cords during surgery, has been conducted since 2011. The study has covered a total of 16 patients over a five-year-period. Permission for the study was approved in 2011, and the treatment was started in January 2012.

Karolinska University Hospital and Karolinska Institutet have had an ongoing dialogue with the relevant authorities over the years. In March 2016 the licensing responsibility was transferred from the Health and Social Care Inspectorate to the Medical Products Agency, and in conjuction with this existing permits expired. Pending a new permit, the studies have been stopped. As of August 2015, no new treatments have been started, only checks of already initiated treatments. The criticism directed at Karolinska Institutet and the researcher responsible for the study is therefore unfounded. Karolinska Institutet have asked the Medical Products Agency for a clarification.

About six percent of the population have voice disorders. A smaller group of patients have severe hoarseness or complete loss of the voice because of scarring tissue on the vocal cords. This often leads to severe communication disability, unemployment or sick leave. Currently no effective permanent treatment for these patients.