Toxicological evaluation of exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells.
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.
['Ha|Dae Hyun|DH|', 'Kim|Sun-Don|SD|', 'Lee|Joon|J|', 'Kwon|Hyuck Hoon|HH|', 'Park|Gyeong-Hun|GH|', 'Yang|Steve Hoseong|SH|', 'Jung|Jae Yoon|JY|', 'Lee|Jun Ho|JH|', 'Park|Sang Rae|SR|', 'Youn|Jinkwon|J|', 'Lee|Sang Hee|SH|', 'Kim|Ji Eun|JE|', 'Lim|Jihye|J|', 'Lee|Hyun-Kul|HK|', 'Cho|Byong Seung|BS|', 'Yi|Yong Weon|YW|']
D000279:Administration, Cutaneous D000818:Animals D041702:BALB 3T3 Cells D055354:Exosomes D005123:Eye D005260:Female D006801:Humans D059630:Mesenchymal Stem Cells D051379:Mice D000067996:RAW 264.7 Cells D017207:Rats, Sprague-Dawley D012867:Skin D018675:Toxicity Tests
Toxicology Exosomes Safety Skin Adipose tissue-derived mesenchymal stem cells (ASCs)