Page 39 - SaxoCell Annual Report22/23

Reg. MSC-PreStiGe
Med.

The project objective of MSC-PreStiGe is to develop an industrial value chain for mesenchymal
stromal cells (MSCs), including active ingredient production, drug production and clinical
application.

The newly developed active ingredient Desacell® exploits the immunomodulatory capabilities of
MSCs from umbilical cord tissue. Due to their enormous expansion potential, cell products from
one umbilical cord can be used to treat several patients, with the initial focus on severe acute
graft-versus-host disease (GvHD) following allogeneic stem cell transplantation.

Project lead: Mario Rüdiger

Partners: TUD Dresden University of Technology, Dresden University Hospital, DKMS
Stammzellbank gGmbH, MDTB Cells GmbH

In order to establish Desacell® as a novel MSC-based therapeutic, the entire target process was
first extracted from the established proof-of-concept and the differences to the future
manufacturer were identified. Furthermore, GMP-compliant approaches to resolve these
differences were developed and the specifications for industrial scaling as well as an
implementation plan for the process transfer were elaborated. The implementation including the
necessary accompanying investments could consequently be started.

In addition, the prerequisites for a potentially targeted clinical intervention with Desacell® as well
as complementary activities for further value-adding stages and products were created to prepare
for the international use of Desacell® in large-scale studies and subsequent regulatory submissions
for indications with high medical need. This includes research and development activities to
predict the potential success of the clinical use of Desacell® as well as the characterization of the
mode of action of Desacell® by establishing and validating an effector cell-free, highly
reproducible, standardized and automatable quality control assay based on Fas ligand stimulation,
which allows the determination of the anti-inflammatory capacity of MSC from umbilical cord
tissue (UC-MSC).

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