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Article History

Received: 10 April 2024

Accepted: 3 October 2024

First Online: 9 November 2024

Declarations

:

: The study does not include a clinical trial, therefore a consent to participate and the declaration of Helsinki—Ethical principles for medical research involving human subjects are not applicable. Experiments used human induced pluripotent stem cells purchased from REPROCELL (Cat#RCRP005N) and iXCells (Cat#NCRM-1, & NCRM-4) that have had their IRB approval documents and informed consents examined by National Institute of Neurological Disorders and Stroke to ensure that voluntary informed consent was obtained from the donor. The title of the project is, “Identifying and Optimizing Critical Process Parameters for Large-Scale Manufacturing of iPSC Derived Insulin-Producing β-cells”. All experiments were performed at Trailhead Biosystems. Approval and oversight of the project were performed by PhD committee at The Cleveland State University and approved on the 19th day of July 2022. No formal oversight committee was used for these reasons, so no approval number is associated with the study. However, full institutional approval was given by Trailhead Biosystems for all aspects of the study and Trailhead Biosystems does abide by all the ethical principles and guidelines established by the International Society of Stem Cell Research (ISSCR).

: Not applicable.

: J.J. is founder of and shareholder of Trailhead Biosystems, Inc., Beachwood, OH, USA. M. B. is a shareholder in Trailhead Biosystems, Inc., Beachwood OH. This work has been filed as US Provisional Application No. application pending.