Clinical Research Priority Program
From basic research to the clinic: Novel tissue engineered skin grafts for Zurich. After more than 11 years of research the Tissue Biology Research Unit (TBRU) of the Department of Surgery of the Children's Hospital in Zurich has come up with new skin grafts for Regenerative and Transplantation Medicine. The complex, bioengineered skin grafts resemble the properties of normal human skin as closely as possible.
Notably, the close collaboration between the PediatricBurn Center of the Department of Surgery of the Children's Hospital in Zurich and the TBRU revealed that the above-mentioned skin grafts can be transplanted in just one surgical intervention. The new skin grafts are intended to be applied in clinical disciplines, such as Burn and Plastic Surgery and Dermatology, in Zurich and in Europe. The development of the grafts was, and is, based on findings gained by the knowledge and methods of basic research in cell and molecular biology. The translational medical project outlined here aims at Clinical Trials that will be undertaken in 2013 in close collaboration with our Pediatric Burn Center, with the Clinical Trial Center (CTC) and the Swiss Center for Regenerative Medicine (SCRM).
Scientific Goal of the Clinical Priority Program (KFSP): Translating experimental findings into clinical application. The following measures have to be taken:
- A novel generation of skin grafts (containing a capillary network and/or a permanent and proliferating melanocyte fraction) have to be produced in a clinically relevant size (7 x 7 cm or 10 x 10 cm) and in medical grade quality.
- To achieve this, we have to produce collagen hydrogels, into which fibroblasts and onto which keratinocytes have to be seeded. The appropriate hydrogel compression devices and transwell membrane-containing culture devices have to be developed and produced.
- Pre-clinical toxicology studies (under GLP conditions) have to be performed.
- GMP and GCP-conform production conditions and regulatory requirements have to be met.
- All used components required for production have to be selected and purchased in medical grade quality.
- In process controls have to be set up.
- Study protocols have to be adapted.
- Phase I Clinical Studies have to be started.
Clinical Research Priority Programs (CRPP) Link
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