Comprehensive regulatory and developmental landscape of cell-scaffold combination therapies for osteoarthritis

초록

Introduction: Osteoarthritis (OA) is a common degenerative joint disease with rising prevalence in aging population. Regen-erative approaches such as autologous chondrocyte implantation (ACI) and stem cell-based therapies show promise but face limitations due to reduced cell viability and poor long-term stability. Recently, combining stem cells with biodegradable scaffolds has emerged as a promising strategy to improve cell survival and tissue regeneration. Methods: This study compares representative approved OA-related cell-based products (CARTISTEM [UCB-MSC], JACC [ACI-Scaffold], and MACI [ACI-Scaffold]) to elucidate their developmental characteristics and regulatory pathways. It also reviews nonclinical and clinical evaluation criteria, current regulatory guidelines, and the global clinical development pipeline, to provide scientific and regulatory insights that support the advancement of future OA-related cell–scaffold combination therapies. Results: The comparative analysis identified differences in cellular origin, scaffold use, regulatory classification, and evidence requirements across products. These differences were associated with distinct regulatory expectations and development strategies, particularly for scaffold-containing products requiring biomaterial-related safety evaluation. The study also derived key development considerations relevant to future OA-related cell–scaffold combination therapies. Conclusions: Cell–scaffold combination products require product-specific regulatory approaches and multidisciplinary evaluation. Early regulatory engagement and greater international harmonization may improve development efficiency, regulatory predictability, and the advancement of future OA-related regenerative therapies. © 2026 The Author(s). Published by Elsevier BV on behalf of The Japanese Society for Regenerative Medicine. This is an open access article under the CC BY-NC-ND license. http://creativecommons.org/licenses/by-nc-nd/4.0/

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