Toxicological evaluation of exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells

Dae Hyun Ha, Sun Don Kim, Joon Lee, Hyuck Hoon Kwon, Gyeong Hun Park, Steve Hoseong Yang, Jae Yoon Jung, Jun Ho Lee, Sang Rae Park, Jinkwon Youn, Sang Hee Lee, Ji Eun Kim, Jihye Lim, Hyun Kul Lee, Byong Seung Cho, Yong Weon Yi

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


Several studies report that the therapeutic mechanism of action of mesenchymal stem/stromal cells (MSCs) is mainly mediated by paracrine factors that are released from MSCs such as exosomes. Exosomes are nano-sized extracellular vesicles that are transferred to target cells for cell-to-cell communication. Although MSC-derived exosomes (MSC-exosomes) are suggested as novel cell-free therapeutics for various human diseases, evaluation studies for the safety and toxicity of MSC-exosomes are limited. The purpose of our study was to evaluate the toxicological profile, including skin sensitization, photosensitization, eye and skin irritation, and acute oral toxicity using exosomes derived from human adipose tissue-derived MSCs (ASC-exosomes) in accordance with the OECD guidelines and the principles of Good Laboratory Practice. The ASC-exosomes were classified as a potential non-sensitizer in the skin sensitization test, UN GHS no category in the eye irritation test, and as a skin non-irritant in the skin irritation test, and did not induce any toxicity in the phototoxicity test or in acute oral toxicity testing. Our findings are the first to suggest that ASC-exosomes are safe for use as a topical treatment, with no adverse effects in toxicological testing, and have potential application as a therapeutic agent, cosmetic ingredient, or for other biological uses.

Original languageEnglish (US)
Article number104686
JournalRegulatory Toxicology and Pharmacology
StatePublished - Aug 2020


  • Adipose tissue-derived mesenchymal stem cells (ASCs)
  • Exosomes
  • Safety
  • Skin
  • Toxicology

ASJC Scopus subject areas

  • Toxicology


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