Transplantation of keratinocytes (skin cells) for severe burn injuries
In 2017, Uppsala University Hospital was the first in the country to obtain a manufacturing license from the Swedish Medical Products Agency for the cultivation of keratinocytes (skin cells) for the treatment of severely burned patients.
Autologous keratinocytes have been available as a clinical therapy since the 1980s and were previously governed by different regulations than those for advanced therapy medicinal products (ATMP). The current authorization falls within the scope of the hospital exemption, which allows healthcare providers to treat patients with advanced therapy medicinal products without market authorization.
For patients with severe burns there are several treatment strategies; autologous partial thickness skin - if skin is available, allogeneic skin - which acts as a temporary biological dressing and has a wound healing effect, and autologous keratinocytes - which is used for patients with burns >50% and is a very important part of a life-saving treatment for patients where other treatment options are few. The production of autologous (patient-own) keratinocytes takes place at the Tissue Establishment at the Department of Plastic and Maxillofacial Surgery, Uppsala University Hospital.
Listen to Alexandra Karström talk about the treatment of severe burns.
Since 2010, the Burn Centre at Uppsala University Hospital has been one of two centres in the country with a mandate for national specialized medical care (NHV) of patients with burn injuries. Specialists in burn care guide emergency departments throughout the country, around the clock, and care for patients of all ages who have suffered burns of varying severity.
Other activities at the tissue establishment include building up a Swedish skin bank for donated allogeneic skin as a biological wound healing dressing but can also be processed into a permanent subcutaneous substitute. Skin donation is therefore an important aspect of the activity - there is a great need, and an increased supply could allow more patient groups to receive treatment with donated allogeneic skin.
The tissue establishment thus holds a license as a tissue establishment from the Swedish Health and Social Care Inspectorate (IVO) and the Swedish Medical Products Agency, as well as a manufacturing license from the Swedish Medical Products Agency for autologous keratinocytes within the framework of the hospital exemption. The permit from IVO exists for allogeneic donor skin and the handling of autologous patient skin.
Foto: patient receiving treatment at Burn Centre (left) and microscopic image of keratinocytes (right).