Die Rolle transfusionsmedizinischer Einrichtungen bei der Implementierung zugelassener CAR-T-Zell-Therapien

Humpe, Andreas; Koerper, Sixten; Schäfer, Richard; Klump, Hannes und Worel, Nina (2019): Die Rolle transfusionsmedizinischer Einrichtungen bei der Implementierung zugelassener CAR-T-Zell-Therapien. In: Transfusionsmedizin, Bd. 9, Nr. 3: S. 168-172

Abstract

For many decades, the only established individualized, curative cellular therapy for patients with various hematological diseases was the transplantation of autologous or allogeneic hematopoietic stem and progenitor cell preparations following conditioning therapy as an individualized therapeutic option for patients with various hematological diseases. From a legal point of view, such transplants are only minimally manipulated (i. e. centrifugation, concentration, dilution, immunomagnetic enrichment or depletion, cryopreservation). In Europe, harvest, processing, quality control, and release of such products are usually performed by Transfusion Medicine departments. In August 2018 autologous chimeric antigen receptor T cells (CAR-T cells) were approved by the European Medicines Agency (EMA) and are, since then, commercially available in several European countries including Germany for individualized therapy of patients with certain hematological malignancies caused by CD19(+) B cells. In a joint session of the working groups "Stem Cell Transplantation and Cellular Therapy" and "Preparative and Therapeutic Apheresis" of the German Society of Transfusion Medicine and Immunohematology (DGTI) in Frankfurt on October 19, 2018 the topic "Commercially available CAR-T cell therapies ante portas: role of Transfusion Medicine departments" was discussed. In particular, subjects of discussion were aspects of financial reimbursement, legal and regulatory framework requirements and definitions of responsibilities and duties between the party supplying the starting material, the pharmaceutical company and the clinicians were discussed.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 2191-8805
• Sprache: Deutsch