Germany approves Rheacell’s cell therapy product
Amesanar® for the use in patients with chronic wounds
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® is made of allogeneic ABCB5-positive mesenchymal stromal cells. This Advanced Therapy
Medicinal Product (ATMP) manufactured by Ticeba GmbH from donor skin can be used in patients with chronic wounds caused by chronic venous insufficiency (see CVU_Pictures_PR). 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.
08/10/2021
Germany approves Rheacell’s cell therapy product Amesanar® for the use in patients with chronic wounds
Germany approves Rheacell’s cell therapy product
Amesanar® for the use in patients with chronic wounds
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® is made of allogeneic ABCB5-positive mesenchymal stromal cells. This Advanced Therapy
Medicinal Product (ATMP) manufactured by Ticeba GmbH from donor skin can be used in patients with chronic wounds caused by chronic venous insufficiency (see CVU_Pictures_PR). 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.
08/10/2021
COMMENTS ARE OFF THIS POST