@phdthesis{Bleuel2021, author = {Bleuel, Gabriel}, title = {Entwicklung und Validierung eines quantitativen Verfahrens zur Beurteilung der Viabilit{\"a}t von entsprechend der GMP-Richtlinien hergestellter Knorpelimplantate f{\"u}r das Knie}, doi = {10.25972/OPUS-24248}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-242481}, school = {Universit{\"a}t W{\"u}rzburg}, year = {2021}, abstract = {Due to the reversing age pyramid in Germany, more and more people are already suffering from joint cartilage damage. But not only age, but also accidents and sports injuries and being overweight can lead to irreversible cartilage defects. Although there are various treatment options, the previous methods cannot be considered a permanent cure. As part of the international research project BIO-CHIP, a promising treatment method with novel drugs was to be investigated. The patient's own cartilage cells from the nose serve as the starting material for the drug, a manufactured cartilage implant. These are isolated, multiplied and ultimately cultivated on a matrix to form a cartilage implant. In addition to toxicological and biological safety tests, an essential prerequisite for the approval of the implant is the assessment of the viability. This was previously carried out on the basis of histology from the pathology department. The aim of the present work was the development and validation of a standardized and objective viability test for the chondrocytes within the cartilage matrix. For this, the LDH was used as a marker for irreversibly damaged cells. The LDH concentration could be measured with the CyQuant LDH assay by measuring the absorption. It could be proven that LDH has the required stability and detectability in the medium. With the help of the lysis, of cultivated mini-cartilage implants, the maximum achievable LDH concentrations could be determined. A calibration curve was generated using these concentrations. This serves to assess the viability of future measured absorptions of the supernatant medium. The developed method does not require any invasive interventions on the implant and is characterized by its simple implementation, since only the protrusion has to be measured. The validation of the method certified a high level of robustness, linearity, accuracy and precision.}, subject = {Hyaliner Knorpel}, language = {de} }