One of our principal tasks is to design and coordinate clinical studies to test the therapeutic utility of Miltenyi Biotec’s clinical products in areas such as regenerative medicine and stem cell therapy, with an emphasis on hemato-oncological, infectious, and cardiovascular disease, and immunotherapy. Working with many internationally recognized professionals in centers throughout the world, we carry out trials that range from safety/feasibility (phase I/II) to pivotal stage (phase III) and post-market surveillance trials.
A number of MACS Technology cell separation products have been developed as CE-marked medical devices for clinical use. The CliniMACS System, for example, enables the preparation of pure cell products for cellular therapy applications. The Therasorb apheresis treatment platform is already being used to treat patients by selective removal of pathogenic substances, such as autoimmune globulins, LDL and IgE, from their plasma.
We work together with our Research and Development and Reagent Production teams in expanding our portfolio of innovative GMP products, thus assisting the advancement of cellular therapy approaches to treatment of disease.