Therapeutics

Medicyte goes therapeutic...

Conventional pharmaceutical treatments are generally limited in their applicability to treat or cure injured or diseased tissues and organs. In these cases, transplantation is the first choice of therapy; however, transplantation in patients is severely limited by the availability of compatible donors.

Tissue engineering could offer a potential alternative by implantation of an engineered biological substitute (artificial organs) to restore or re-establish normal functions.

The current market for such cell-based regenerative medicine applications amounts to several hundred million Euros and is projected to grow with a compound annual growth rate of 25% to 30% to a multi-billion Euro market over the next decade.

Building organs requires multiple components to generate functional tissue with connective tissue, blood vessels and supporting cells. Medicyte is covering all these aspects in different projects. The combined experience of these projects enables Medicyte's own development of implantable constructs or "bioartificial" organs for therapeutic applications.

Starting with the 3D structure, a suitable scaffold is needed. In collaboration with a number of partners, Medicyte has been investigating upcyte^® Hepatocyte functionality on 3D plates.

Furthermore, cell-cell interactions are needed to promote organ functionality. Medicyte is part of the prestigious international research project HeMiBio (information leaflet ). The Hepatic Microfluidic Bioreactor (HeMiBio) mimics human liver, reproducing the heterotypic interactions between the parenchymal (hepatocytes) and non-parenchymal cells (e.g. hepatic stellate cells and hepatic sinusoidal endothelial cells). All three liver cells are expanded using our upcyte^® technology, so that the source of these cells is not limited.

Medicyte has initiated a unique European-wide Project with the aim to design a biomimetic bioartificial liver (Re-Liver). The aim of Re-Liver Consortium, comprising Medicyte, The Electrospinning Company and the Universities of Manchester and Pisa , is to reconstitute a standardized and reproducible bioartificial liver organoid (BLO), using healthy human liver as an architectural and biomaterial template. The BLO is classified according to the EMA criteria as a cell-based medicinal product, and is a highly innovative and complex medicine. The Re-Liver project could result in a device that can be used for minimal invasive implantation to treat metabolic diseases, thus minimizing the transition from concept to clinic. Last but not least, the BLO could be an alternative to solid organ transplantation - giving new hope to over 10,000 people waiting for a liver transplant in the EU .

Another big issue of tissue engineering is the (neo-) vascularization that is essential for the supply of oxygen and nutrients to the cells in the constructs. Together with numerous partners, Medicyte is working on the development of vascularized transplants. In this project, called BioVaSc (Biological Vascularised Scaffold), patients own cells are expanded in vitro on a de-cellularized organ scaffold. One of the challenges is the appropriate vascularization of the newly formed tissue using cells generated from Medicyte's upcyte^® technology. The goal is the in vitro generation of suitably vascularised human organ tissue for transplantation.

In the international collaboration project, VascuBone , Medicyte is collaborating with the Fraunhofer Institute , Johnson & Johnson Medical, and other European institutes and companies to develop a "toolbox" for bone tissue regeneration. The toolbox will include a range of biocompatible biomaterials and cell types, FDA approved growth factors, material modification technologies, as well as simulation and analytical tools which can be combined for specific medical needs. Medicyte´s contribution is to supply vericyte^®microvascular endothelial cells for the vascularization of newly formed tissue.

A cell therapeutic initiative involving Medicyte, Primacyt (Germany) and the University of Tübingen (Germany) is to optimize the metabolic and proliferative capacity of upcyte^® hepatocytes. Another aim is to develop optimal cryopreservation conditions and cell media for the culture of upcyte^® hepatocytes, so that they can be used for therapeutic applications.