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Service project

Service project: Investigations relating to the optimal injection of regeneration-competent mesenchymal stem cells and the role of local inflammation in the cell-based treatment of sphincter defects

The clinical application of MSC expanded ex vivo requires human cell transplants to be cultivated and manufactured in accordance with the basic principles of good manufacturing practice (GMP) as laid down in the German Medicinal Products Act (AMG) and the EU’s GMP guidelines. The Paul Ehrlich Institute, which is the German authority that grants cell transplant manufacturing authorisations and others, therefore requires animal proteins to be replaced by human blood products and recombinant proteins.

The human application of MSCs was initially mainly focused on assessing the compatibility and safety of cellular transplants. In this context, researchers at the Tübingen University Hospital were able to test the clinical application of autologous and allogeneic MSCs produced under GMP conditions in small patient cohorts with avascular osteonecroses as well as in a group of paediatric patients who had previously had haematopoietic stem cells transplanted and developed acute/chronic GvHD (graft-versus-host disease). The researchers found that the MSC grafts were safe and well tolerated by the transplant patients.

The isolation/expansion of MSCs from bone marrow is a well-established procedure and their application as cellular transplant of GMP quality will be applied to in vitro expanded placental MSCs as well as to myogenic bone marrow and/or placental MSCs. Mesenchymal stem cells have shown huge potential for the treatment of urinary incontinence. The successful application of undifferentiated and in vitro differentiated myogenic MSCs into the bladder neck has already been demonstrated in a xenogenic rat model for the regenerative treatment of urethral sphincter defects. The animals tolerated both cell populations well and histological examinations showed the excellent integration of the cells into the target tissue.

The service project is therefore aimed at obtaining the authorisation to produce placental MSCs and differentiated myogenic bone marrow and/or placental MSCs for subsequent use in advanced clinical studies to assess their potential in restoring sphincter function.

Prof. Dr. med. Arnulf Stenzl

Department of Urology, Tübingen University Hospital
Medical Director

Dr. rer. nat. Martin Vaegler

Department of Urology, Tübingen University Hospital
Senior scientist, Biotechnology Center (BTZ)

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