REPORT. In the report, Bengt Gerdin highlights several details of four cases where stem cell-treated transplanted organs were used in 2011-2012. Failures to seek permission for the procedures performed on the patients should be seen in light of the few available alternative treatments and unclear legislation at the time.
The report examined four transplants, one trachea transplant and three transplants of blood vessels in the abdomens of children.
“The procedures in these four cases used a previously developed technique with donor organs where the organs’ own cells were removed, and where the method was further developed by inserting the patient’s own stem cells into the organs to achieve normal cell function,” says Lars Grip director of RD&E at Sahlgrenska University Hospital.
Because the patients were treated using an unproven technique, the Västra Götaland Region, Sahlgrenska University Hospital and Sahlgrenska Academy at the University of Gothenburg initiated an external review to clarify the circumstances of the four cases and examine what happened before and after the procedures and whether applicable legislation pf the time was adhered to.
Bengt Gerdin, professor emeritus at Uppsala University, Professor Kjell Asplund and Senior Professor Olle Lindvall were appointed to conduct this study. The report is now complete and the investigators conclude:
- The four patients were critically ill and had major difficulties in their daily lives with lower quality of life as a result, and the risk of deterioration and, at worst, death was significant.
- Other forms of treatment were not apparent. For the three children, liver transplants were an alternative treatment.
- The best interests of the patients were at the forefront, and the primary aim was to give the patients the best possible care.
- Consent was given by the patients and/or ethical considerations were weighed before the procedures but documentation of these considerations is inadequate.
- Other documentation concerning the care, treatment and decisions is insufficient.
- Contact with various authorities and ethics specialists occurred, although these contacts were not documented in writing. In many cases they have been verified verbally afterwards.
The report shows that the relevant legislation was being revised at the time and that the introduction of new laws and regulations was moving forward slowly. Even so, the report authors are critical of having not sought permission for the production of the stem cell-treated transplants and for giving a patient substances that were not registered as medicines.
The authors point out that the relevant development work is judged to have been based on scientific premises and therefore, according to the Ethical Review Act, is considered research. For this reason, the procedures should have required the approval of the regional ethical review board.
“We believe that the report highlights several issues of great fundamental importance, and we will further review our internal procedures for the development and introduction of new methods. To help in this work, we have asked of the external investigators to provide a proposal,” says Lars Grip.
In anticipation of the investigators’ proposal, on March 22 of this year hospital management decided to revise procedures for the introduction of new methods in health care.
The aim is to ensure a transparent transition from research and development to be able to introduce new methods in the hospital. The investigators are expected to submit a similar proposal in January 2017.
