Durchflusszytometrische Kontrolle von MSC-Produkten im Rahmen der Herstellung als ATMP für klinische Prüfungen

Zusammenfassung

Ex vivo expandierte mesenchymale Stroma-/Stammzellen (MSC) werden mittlerweile aus zahlreichen Geweben isoliert und in klinischen Studien der regenerativen Medizin und der immunmodulatorischen Therapie eingesetzt. Die bisher existierenden Definitionen der MSC sind zwar sehr allgemein gefasst, Kriterien zur Verwendung von MSC in unterschiedlichen klinischen Einsatzgebieten bedürfen jedoch ggf. einer angepassten Spezifikation. Wir stellen hier die Vorgehensweise der durchflusszytometrischen Charakterisierung von MSC zum Einsatz in klinischen Prüfungen zur Knochenregeneration vor und diskutieren die Notwendigkeit, Spezifikationen für MSC in Abhängigkeit von ihrem jeweiligen Einsatzgebiet zu definieren.

Abstract

Ex vivo expanded mesenchymal stromal/stem cells (MSC) isolated from various tissues are subject of an increasing number of clinical trials in regenerative as well as immunomodulatory therapy. Existing definitions for MSC do not necessarily take into account that MSC used for different clinical applications need different specifications. We present a flow cytometry based definition of MSC for clinical trials in bone regeneration and critically discuss the need for specific definitions of MSC, depending on their field of clinical application.

Schlüsselwörter

Durchflusszytometrie - mesenchymale Stromazellen - Arzneimittel für neuartige Therapien (ATMP) - GMP

Key words

flow cytometry - mesenchymal stromal cells - advanced therapy medicinal products (ATMP) - GMP

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