logo_ukrThe main duties of the University Hospital Regensburg are patient care, research and teaching.

The University Hospital is committed to provide patients with the best level of medical care possible at the present time, and to contribute to the further development of medicine by internationally acclaimed research and by providing top medical training for doctors and junior scientists.

It has become one of the most modern as well as one of the most efficient hospitals in Germany since its establishment in 1992.

The José Carreras Centre for Somatic Cell Therapy (JCC) at the University Hospital Regensburg is a state of the art GMP- and cleanroom facility specifically built for the conduction of early clinical trials involving advanced therapeutic medicinal products. The JCC received a manufacturing licence for the production of in vitro expanded regulatory T cells in 2012 and is the first European Centre for GMP compliant and GMP certified high speed FACS-sorting of cellular medicinal products.

Further technical expertise of the José Carreras Centre is cell separation, depletion and enrichment using magnet activated cell sorting technology (MACS).

Dr. Hauser is head of production in the José Carreras Centre and has the expertise as qualified person for ATMPs.

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Lead Scientist: Dr. Andrea Hauser

Institution: Universitätsklinikum Regensburg
Position: Pharmacist

Contact Information

email: Andrea.Hauser[at]klinik.uni-regensburg.de
Telephone: (+) 49 94 19445101
Address: Germany

Dr. Andrea Hauser is a trained pharmacist and together with Prof. Dr. Matthias Edinger (MD) jointly heading the José Carreras Centre for Somatic Cell Therapy (JCC), a state of the art GMP- and cleanroom facility specifically built for the conduction of early clinical trials involving advanced therapeutic medicinal products. Dr. Hauser used to work with the local governmental authority (Government of Upper Bavaria, Central Authority for Supervision of Medical Products) supervising GMP-facilities and conducting numerous GMP- and GCP-inspections with focus on cells and tissues.

The José Carreras Centre received a manufacturing licence for the production of in vitro expanded regulatory T cells in 2012 and is the first European Centre for GMP compliant and GMP certified high speed FACS-sorting of cellular medicinal products. Start of an investigator initiated, multicentre, phase I/II clinical trial with these in vitro expanded regulatory T cells in the setting of acute GvHD is planned for June 2013 where the JCC will function as central manufacturing site for all participating centres. Further technical expertise of the José Carreras Centre is cell separation, depletion and enrichment using magnet activated cell sorting technology (MACS).

In this field the JCC collaborates with Miltenyi Biotec for the development of new GMP-compatible cell separation technologies (in parts co-funded by the German Ministry for Science and Education, BMBF). Further cell products under investigation are mesenchymal stroma cells, antigen-specific T cells as well as CD4+CD25+ regulatory T cells for the treatment of allogeneic stem cell transplant recipients, patients after organ transplantation and patients with autoimmune diseases.

Dr. Hauser is head of production in the José Carreras Centre and has the expertise as qualified person for ATMPs.

Tasks: With her regulatory and pharmaceutical expertise Dr Hauser is an essential partner in WP2 for the development of training programmes with focus on regulatory aspects and process related issues and she is partner in WP3, 4 and 5.

Selected publications:

1. Hoffmann P, Boeld TJ, Eder R, Huehn J, Floess S, Wieczorek G, Olek S, Dietmaier W, Andreesen R, Edinger M. (2009). Loss of FOXP3 expression in natural human CD4+CD25+ regulatory T cells upon repetitive in vitro stimulation. Eur. J. Immunol. 39(4): 1088-97.

2. Hoffmann P, Boeld TJ, Eder R, Piseshka B, Dada A, Niemand C, Assenmacher M, Orso E, Andreesen R, Holler E & M Edinger (2006). Isolation of CD4+CD25high regulatory T cells for clinical trials, Biol. Blood & Marrow Transpl. 12(3): 267-74.

3. Hoffmann P, Eder R, Boeld TJ, Doser K, Piseshka B, Andreesen R & M Edinger (2006). Only the CD45RA+ subpopulation of CD4+CD25high T cells gives rise to homogeneous regulatory T cell lines upon in vitro expansion. Blood 108(13):4260-7.

4. Hoffmann, P., Eder, R., Kunz-Schughart, L.A., Andreesen, R., Edinger, M. (2004). Large scale in vitro expansion of polyclonal human CD4+CD25high regulatory T cells. Blood 104: 895-903.

5. Edinger, M., Hoffmann, P., Ermann, J., Drago, K., Fathman, C.G., Strober, S., Negrin, R.S. (2003). CD4+CD25+ regulatory T cells preserve graft-versus-tumor activity while inhibiting graft-versus host disease after bone marrow transplantation. Nature Medicine, 9(9), 1144-50.