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

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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.
License: Creative Commons Attribution 3.0
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Date of publication of this fulltext: 14 Dec 2021 07:27


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 ...


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