In question: the scientific value of preclinical safety pharmacology and toxicology studies with cell-based therapies

URN to cite this document:: urn:nbn:de:bvb:355-epub-511846
DOI to cite this document:: 10.5283/epub.51184

Broichhausen, Christiane ; Riquelme, Paloma

; Ahrens, Norbert

; Wege, Anja K.

; Koehl, Gudrun E. ; Schlitt, Hans J.

; Banas, Bernhard

; Fändrich, Fred ; Geissler, Edward K.

; Hutchinson, James A.

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Date of publication of this fulltext: 14 Dec 2021 07:27

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Abstract

A new cell-based medicinal product containing human regulatory macrophages, known as Mreg_UKR, has been developed and conforms to expectations of a therapeutic drug. Here, Mreg_UKR was subjected to pharmacokinetic, safety pharmacology, and toxicological testing, which identified no adverse reactions. These results would normally be interpreted as evidence of the probable clinical safety of ...