The company has recently launched an innovative full-thickness skin transplant for healing wounds using the patient’s own cells. Within the framework of the Users’ Centre for Regenerative Medicine in the Neckar-Alb and Stuttgart health region (REGiNA), which is currently in the process of being established, AgenoLab is being supported by the German Federal Ministry of Education and Research (BMBF) with just short of Euro 1 million for two projects, one of which is the development of the above-mentioned full-thickness skin transplant.

Cosmetics, ointments, chemicals, detergents and medical products all have to undergo skin tolerance tests before they can be launched on the market. The life science and biotechnology company AgenoLab GmbH & Co. KG, founded in 2007, is equipped with a GMP laboratory covering 600 square metres, where scientists are developing three-dimensional skin models for test purposes. The GMP quality standard, based on state-of-the-art technology and highly trained staff, ensures optimum safety and highest product quality.

The human cell associations grown in the laboratory consist of the subcutis and a multi-layer epidermis with a horned layer (stratum corneum). These cell groups can eliminate the need for animal testing. Human skin, for example left over from operations, is used to build the requisite skin model. Skin cells in the tissue are isolated from either the epidermis or subcutis. Both variants are equally suitable for cosmetic, pharmacological, immunological and molecular biology trials. “We are the first biotechnology company in Germany to use the xCELLigence cell assay system to conduct label-free real time monitoring of cells and perform online measurements of their biological effectiveness. The latest generation of equipment even makes it possible to measure the migration properties of cells,” explains Dr. Andreas Emmendörffer, Research Director at AgenoLab. “This innovative cell culture technology is supported by cutting-edge molecular analysis methods for determining the risks posed by substances, raw materials and ingredients, for example. This makes it possible to reduce the number of animal experiments, which gives rise to many benefits over and above the ethical implications.” For instance, in vitro cell tests can be used to verify the tolerance of cosmetics, pharmaceuticals, chemicals and medical products in line with the EU chemical regulation REACH.

Furthermore, at the end of 2008, the young company unveiled a licensed technology for the production of autologous skin transplants grown from patients’ own skin, known as KeraSeed. Using this technology, skin cells from biopsies are supplied in a fibrin adhesive (physiological two-component adhesive of biological origin) for transplantation. This procedure is used, for example, to treat burns victims, patients requiring plastic surgery and for the treatment of chronic wounds. “Three million people in Germany suffer from chronic wounds that often do not heal despite targeted and systematic local treatment. Our skin transplant can help close the wounds and thus ease the pain,” says Dr. Emmendörffer, adding that data from a multicentric study (phase IIb/III) were published for this product in 2007. “Additionally, AgenoLab has the technology required to grow autologous melanocytes to treat vitiligo, which causes depigmentation of the skin.” In this case, the patient’s own healthy pigment cells are extracted from a small skin sample with normal pigmentation. These are then grown in cell culture dishes before they are transplanted in the affected “white” areas, where they produce melanin to create normal pigmentation.

Within the framework of the Users’ Centre for Regenerative Medicine in the Neckar-Alb and Stuttgart health region (REGiNA), which is currently being established, AgenoLab is being supported by the BMBF with Euro 900,000 for two projects, one of which is the development of a full-thickness skin transplant. “In the area of skin and wound treatment, we expect new products, such as those from AgenoLab, to deliver significantly improved healing results,” confirms Dr. Klaus Eichenberg, Managing Director of BioRegio STERN Management GmbH. “It is now important to ensure that innovative procedures such as these are made available through the state healthcare system.”