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Germany approves novel cell therapy extracted from skin

Germany’s Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut) grants RHEACELL national approval for its cell therapy product AMESANAR®for the use in patients with chronic wounds

Heidelberg, 06. October2021 –Chronic wounds not only put great strain on the health system, but also have a major impact on the quality of life of affected patients.

RHEACELL, a German biopharmaceutical company focused on clinical development of novel stem cell therapeutics, has been granted national approval under § 4b of the German Medicinal Products Act for its novel cell therapy product AMESANAR®. AMESANAR® (allogeneic ABCB5-positive mesenchymal stromal cells), manufactured by TICEBA GmbH from donor skin, is an Advanced Therapy Medicinal Product (ATMP) and can be used in patients with chronic wounds caused by chronic venous insufficiency.

The approval represents a major advance for those affected, as well as an important milestone for biopharmaceutical industry efforts directed atthe development of cell-based drugs: This first approval of a somatic cell therapy medicinal product derived from skin validates the concept that translation of highly innovative cell therapies to clinical use is achievable. Currently RHEACELL is preparing for market entry in Germany. AMESANAR® will be available to patients at hospitals and specialized clinics in Germany.

RHEACELL’s ongoing clinical development programs focus not only on chronic wounds, but also on additional serious or rare diseases such as epidermolysis bullosa (butterfly disease), which mainly affects children.

RHEACELL hopes to alleviate the suffering of affected patients by concentrating on the development of cell therapies for rare diseases and diseases where no cure is available.


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