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BCRT and Fraunhofer IZI receive manufacturing authorization for CardAP cells

Another step towards the novel treatment of patients with chronic heart failure

26 July 2018
Scientists at the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) of the Charité – Universitätsmedizin Berlin and the Fraunhofer-Institute for Cell Therapy and Immunology have received the manufacturing authorization for their CardAP cells. The team around Professor Dr. Michael Sittinger and Professor Dr. Carsten Tschöpe succeeded in isolating a completely new cell type from tissue samples of the heart. This cell type offers a treatment option for chronic heart muscle disease that would improve the quality of life of patients. The manufacturing authorisation now granted ensures the quality of the CardAP cell therapy product for patients.

The patient-specific cell products will be manufactured under the strictest quality criteria at the Main Department GMP Cell and Gene Therapy of the Fraunhofer-Institute for Cell Therapy and Immunology in Leipzig. They belong to the advanced therapy medicinal products (ATMPs) and are strictly controlled like conventional medicines. The same high standards apply as with a pharmaceutical company. The experimental research and development of CardAP cells takes place in the BCRT. "The manufacturing authorisation now granted is a crucial step in the translation of this new cell-based therapy from research to the clinic," explains Sittinger, the head of the BCRT's Research Field "In situ Tissue Engineering". Now the prepared phase I and II of the clinical trial can start soon.

CardAP cells are heart tissue-specific cells. They are isolated directly from the patient's own tissue samples of the heart, expanded under clean room conditions and then transplanted back to the same patient. CardAP cells are very promising for a therapy because they improve cardiac function (both after intravenous injection and after injection directly into the heart) and inhibit the death of cells in the heart. Because they are the patient’s own cells, the patient’s body does not reject them.

Partner for the development and marketing of this novel therapy is the biotechnology company CellServe GmbH, a spin-off of the Charité – Universitätsmedizin Berlin. CellServe is currently in final negotiations on the financing of the prepared clinical trial under the German Drug Law. This would allow patients affected in Germany to benefit from the new cardiac cell therapy within a few years.

Contact:

Dr. Marion Haag
Charité – Universitätsmedizin Berlin
Berlin-Brandenburg Center for Regenerative Therapies (BCRT)
Phone: +49 (0)30 450 539 437
E-Mail: marion-renate.haagcharitede

Prof. Dr. Michael Sittinger
Charité – Universitätsmedizin Berlin
Berlin-Brandenburg Center for Regenerative Therapies (BCRT)
Phone: +49 (0)30-450 513 198
E-Mail: michael.sittingercharitede

Dr. Gerno Schmiedeknecht
Fraunhofer Institute for Cell Therapy and Immunology IZI
Perlickstraße 1, D-04103 Leipzig, Germany
Phone: +49 341 35536 9705
E-Mail: gerno.schmiedeknechtizi.fraunhoferde

Links:

Research Field In situ Tissue Engineering at BCRT

Research Field Cardiovascular System at BCRT

Charité – Universitätsmedizin Berlin

CellServe GmbH

Fraunhofer IZI