Toxicological testing of allogeneic secretome derived from peripheral mononuclear cells (APOSEC): a novel cell-free therapeutic agent in skin disease View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

Silvio Wuschko, Alfred Gugerell, Monika Chabicovsky, Helmut Hofbauer, Maria Laggner, Michael Erb, Tobias Ostler, Anja Peterbauer, Susanne Suessner, Svitlana Demyanets, Jost Leuschner, Bernhard Moser, Michael Mildner, Hendrik J. Ankersmit

ABSTRACT

A cell-free approach using secretomes derived from stem cells or peripheral blood mononuclear cells is an active area of regenerative medicine that holds promise for therapies. Regulatory authorities classify these secretomes as biological medicinal products, and non- clinical safety assessment thus falls under the scope of ICH S6. A secretome of stressed peripheral blood mononuclear cells (APOSEC) was successfully tested in a toxicology program, supporting clinical use of the new drug candidate. Here, to allow for topical, dermal treatment of patients with diabetic foot ulcer, several non-clinical safety studies were performed. Acute toxicity (single dose) and neuropharmacological screening were tested intravenously in a rat model. Risk for skin sensitisation was tested in mice. A 4-week intravenous toxicity study in mice and a 4-week subcutaneous toxicity study in minipigs were conducted to cover the clinical setting and application in a rodent and a non-rodent model. Acute and repeated-dose toxicity studies show that APOSEC administered intravenously and subcutaneously does not involve major toxicities or signs of local intolerance at levels above the intended total human maximal dose of 3.3 U/kg/treatment, 200 U/wound/treatment, and 100 U/cm2/treatment. The non-clinical data support the safe topical use of APOSEC in skin diseases related to deficient wound healing. More... »

PAGES

5598

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41598-019-42057-5

DOI

http://dx.doi.org/10.1038/s41598-019-42057-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1113182175

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30944367


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