New criticism of KI: “Research without permission” – Swedish Dagbladet

KI has been caught in my own critique of the research on stem cells. Photo: Izabelle Nordfjell / TT

Now, new critique of the Karolinska Institute’s stem cell research. MPA believes that KI conducted research on patients without the necessary permits and proper control, it reports TV4 News. Patients should not have known that they had been “guinea pigs” in a research project.

of course it is serious that you do not have this independent review of research

It is a treatment of patients with scars on the vocal cords to have lacked permits. According to TV4, the 16 patients treated with their own stem cells for ärrskador on the vocal cords.

When a stem cell is taken from a patient and manipulated, it is considered a drug. This requires not only an examination of the ethics of the project but also permits the use of the drug itself.

Ann Marie Janson Lang, an expert in clinical trials on Lake Medle Agency, sees the incident as serious.

– of course it is serious from our point of view that you do not have this independent review of research projects, as the law says you must have. Not just an ethical review board viewing information to patients, insurance and other things, but also that someone has checked that the drug is safe, she says to TV4.

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Since August 2015, no new treatments started, only checks already started procedures

the state of research should have expired in March 2016, when responsibility was transferred from the National Board of the MPA and new permits have to be applied.

Karolinska Institute responded Monday evening criticism in a press release which said that the criticism of the study was incorrect

” pending the new licenses processed by the FDA, the studies have been stopped. This means that since August 2015, no new treatments started, only checks already started procedures performed. “Writes KI.

The investigator was previously involved in the scandal hit surgeon Paolo Macchiarinis experiments and co-author of one of his studies. She claimed later to have his name removed from the study, according to

Ann Marie Janson Lang from the MPA said to TV4 that the authority is considering to the police hospital where the study may violate the Drug Act.