engleski

Cultured Keratinocytes from the First Licenced Skin Tissue Bank in Croatia

From 30th of December 2012, cultured epithelial autografts (CEA) were classified as ATMP requiring full GMP implementation in all production units, including Tissue Establishments in hospitals. In July 2014 the production facility in our Tissue Bank was officially licensed by Croatian CA for the amniotic membrane banking and CEA production under the hospital exemption rule. According to the national and EU legal requirements we built a laboratory with A and B class of air cleanes. From 2007 we processed skin samples from 45 autologous donors from all of Croatia. Donors’ age varied from 8 months to 74 yrs (mean 30, 01). TBSA was in range of 10-87% (mean 60, 225%) CEA was transplanted in 23 cases. 3 patients died after CEA application (3 days, 3 and 6 months after CEA application, respectively). For surgical mode of CEA application, keratinocytes in subconfluent state were the most frequently used. Compared to postconfluent Rheinwald and Green’s CEA sheets they had smaller portion of terminally differentiated keratinocytes and shorter production time. Moreover, they give us the possibility to be more flexible in operation timing. Simultaneous co-application with fibrin glue prevented CEA suspension of dropping out of the wound bed. It further benefited to wound healing process by its anticoagulant properties. However, the well known fact is that the third degree burn with limited donor sites available, must be prior to all, covered with a skin substitute. At this moment we have intensified our efforts to introduce a new activity: banking of cadaveric skin.

cultured epithelial autografts ; keratinocytes ; ATMP ; GMP ; hospital exemption rule ; cleanroom

nije evidentirano