Publication Name	World Journal of Stem Cells
Manuscript ID	106547
Country	China

Received	2025-03-03 14:09
Peer-Review Started	2025-03-04 01:51
To Make the First Decision
Return for Revision	2025-03-27 10:38
Revised	2025-04-01 15:52
Second Decision	2025-04-30 05:35
Accepted by Journal Editor-in-Chief
Accepted by Executive Editor-in-Chief	2025-05-07 01:33
Articles in Press	2025-05-07 01:33
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript	2025-05-16 07:41
Publish the Manuscript Online	2025-05-26 09:15

ISSN	1948-0210 (online)
Open Access	This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
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Category	Cell & Tissue Engineering
Manuscript Type	Review
Article Title	Quality by design strategy of human mesenchymal stem/stromal cell drug products for the treatment of knee osteoarthritis
Manuscript Source	Invited Manuscript
All Author List	Hao Yu, Fan Zhang, Yi-Chen He and Lei-Sheng Zhang
Funding Agency and Grant Number	Funding Agency Grant Number Taishan Scholar Special Funding tsqnz20240858 Medical and Health Technology Project of Shandong Province 202402050122 Science and Technology Development Plan of Jinan Municipal Health Commission 2024301008 Clinical Medical Science and Technology Innovation Program of Jinan Science and Technology Bureau 202430055 Natural Science Foundation of Jiangxi Province 20224BAB206077 Jiangxi Provincial Leading Talent of “Double Thousand Plan” jxsq2023102017 Gansu Provincial Hospital Intra-Hospital Research Fund Project 22GSSYB-6 The 2022 Master/Doctor/Postdoctoral Program of National Health Commission Key Laboratory of Diagnosis and Therapy of Gastrointestinal Tumor NHCDP2022004, NHCDP2022008
Corresponding Author	Lei-Sheng Zhang, Director, PhD, Professor, National Health Commission Key Laboratory of Diagnosis and Therapy of Gastrointestinal Tumor, Gansu Provincial Hospital, No. 204 West Donggangxi Road, Lanzhou 730000, Gansu Province, China. leisheng_zhang@163.com
Key Words	Mesenchymal stem/stromal cells; Knee osteoarthritis; Quality by design; Critical quality attributes; Critical material attributes
Core Tip	Knee osteoarthritis is one of the leading causes of disability worldwide and has become a high burden due to the multifactorial nature and the deficiency of available disease-modifying treatments. Herein, we review the state-of-the-art literatures of the quality by design strategy of mesenchymal stem/stromal cell drug products for knee osteoarthritis treatment, together with discuss the accompanied principles as well, which will collectively help to reduce the gap between compliant products and the production of compliant good manufacturing practice.
Publish Date	2025-05-26 09:15
Citation	<p>Yu H, Zhang F, He YC, Zhang LS. Quality by design strategy of human mesenchymal stem/stromal cell drug products for the treatment of knee osteoarthritis. <i>World J Stem Cells</i> 2025; 17(5): 106547</p>
URL	https://www.wjgnet.com/1948-0210/full/v17/i5/106547.htm
DOI	https://dx.doi.org/10.4252/wjsc.v17.i5.106547

Full Article (PDF)	WJSC-17-106547-with-cover.pdf
Manuscript File	106547_Auto_Edited_083115.docx
Answering Reviewers	106547-answering-reviewers.pdf
Audio Core Tip	106547-audio.m4a
Conflict-of-Interest Disclosure Form	106547-conflict-of-interest-statement.pdf
Copyright License Agreement	106547-copyright-assignment.pdf
Approved Grant Application Form(s) or Funding Agency Copy of any Approval Document(s)	106547-foundation-statement.pdf
Non-Native Speakers of English Editing Certificate	106547-non-native-speakers.pdf
Peer-review Report	106547-peer-reviews.pdf
Scientific Misconduct Check	106547-scientific-misconduct-check.png
Scientific Editor Work List	106547-scientific-editor-work-list.pdf
CrossCheck Report	106547-crosscheck-report.pdf