Author/Editor		Puhar, Saša; Jeras, Matjaž
Title		Predpisi za pripravke tkivnega inženirstva in za somatsko celično zdravljenje
Translated title		Regulative for tissue engineered medical products and somatic cell therapy
Type		članek
Source		Farm Vestn
Vol. and No.		Letnik 56, št. 3
Publication year		2005
Volume		str. 194-7
Language		slo
Abstract		Tissue engineering is a new and rapidly developing interdisciplinary field of biotechnology, dealing with tissues and organs by applying viable cell-, tissue- and organotypic cultures prepared in vitro. Somatic cell therapy is a part of tissue engineering and it encompasses preparation of viable human cells, cultured ex vivo in a way to achieve sufficient number of cells suitable for the re-implantation into recipient. Beside wanted effect, the application of human cells and tissues may cause transferable diseases and other unwanted effects in the patient. Risk estimation for the recipient is therefore the main criteria for their application. Transmission of infectious diseases thus represents the major threat., along with possible contamination ot cell cultures and the loss of specific cell characteristics occurring during their in vitro manipulation. Due to the complexity of tissue engineered medical products and the lack of clinical experience following their application it is necessary to thoroughly regulate this field in order to assure quality, safety and effectiveness.
Descriptors		CELLS, CULTURED BIOTECHNOLOGY TISSUE THERAPY QUALITY CONTROL