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Authors
Kim, Sang-Heon
Lee, Sung-Hoon
Jin, Jeong-Ah
So, Hyung-Joon
Lee, Jae-Ung
Ji, Min-Jae
Kwon, Eun-Joong
Han, Pyo-Sung
Lee, Hong-Ki
Kang, Tae-Wook http://orcid.org/0000-0002-9498-2265
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Article History
Received: 20 October 2023
Accepted: 30 November 2023
First Online: 10 December 2023
Declarations
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: This study involves the collection of human urine samples as part of the project titled ‘Isolation of Human Urine-derived Stem Cells and Research for Stem Cell Treatments’, which was approved by the Korean Institutional Review Board (Approval No. and Date: P01-201812-31-005, December 20, 2018). In accordance with the Declaration of Helsinki, the donors were informed and consented regarding the purpose of this study, the procedures for collecting and handling human-derived specimens, potential risks or benefits, and the handling, preservation, and disposal of the specimens. This non-clinical study was based on the ‘Standards for Toxicity Study of Pharmaceuticals.’ (MFDS Notification No. 2017-71) and ‘Regulation on Approval and Review of Biological Products’ (MFDS Notification No. 2020–82) by the Korean Ministry of Food and Drug Safety. All animal experiments were conducted at ChemOn Non-clinical Research Inc., a GLP-certified institution, in accordance with the ‘Regulation for Non-clinical Laboratory Studies’ (MFDS 2018-93) and OECD Principles of Good Laboratory Practice (ENV/MC/CHEM(98)17, 1997). The Institutional Animal Care and Use Committee (IACUC) of ChemOn Non-clinical Research Inc. approved and supervised each experiment. (Approval No. and Dates: Single-dose toxicity, 20-M482, September 4, 2020; Repeated-dose toxicity, 20-M750, December 22, 2020; Single-dose distribution, 21-M080, February 18, 2021; Repeated-dose distribution, 2022-0415, May 17, 2022; Repeated-dose tumorigenicity, 20-M757, December 21, 2020).
: Not applicable.
: The authors affiliated with Affiliation 1 and Affiliation 2 are employees of EHLBio Co. Ltd. and EHLCell clinic, with Hong-Ki Lee serving as the CEO of both companies. They declare no competing financial interests, such as holding stocks or any other financial involvement related to the content of this paper. This study was conducted with complete scientific integrity and independence.
