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

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 Mreg_UKR; however, we contend that, owing to their uncertain biological relevance, our data do not fully support this conclusion. This leads us to question whether there is adequate scientific justification for preclinical safety testing of similar novel cell-based medicinal products using animal models. In earlier work, two patients were treated with regulatory macrophages prior to kidney transplantatio

SUBMITTER: Broichhausen C 

PROVIDER: S-EPMC4362366 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature