Document is current

Article History

Received: 27 October 2023

Accepted: 16 June 2024

First Online: 2 July 2024

Declarations

:

: This 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) that have had their IRB approval documents and informed consents examined by National Institute of Neurological Disorders and Stroke to ensure that voluntary consent is obtained from the donor. The title of the project is, “Addressing bioreactor hiPSC aggregate stability, maintenance and scaleup challenges using a Design of Experiment approach”. All experiments were performed at and approved by Trailhead Biosystems. Approval and oversight of the project were performed by PhD committee at The Cleveland State University and was approved on the 19th day of July 2022.

: The authors declare that artificial intelligence is not used in this study.

: Not applicable.

: J.J. is founder and a 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. 63/572,658.