Evidence map›Paper›PMID 42859758›Full record

ArticleRegenerative therapy2026

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

Yunbin Choi, Seungyong Lee, Soobin Moon, Chaeeun Shin, Min Park, Mai Zakarya, Jihong Lim, Kyenghee Kwon

Abstract read
In one paragraph

Article in Regenerative therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yunbin ChoiDepartment of Bio-Pharmaceutical Industry, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Seungyong LeeDepartment of Food & Medical Products Regulatory Policy, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Soobin MoonDepartment of Food & Medical Products Regulatory Policy, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Chaeeun ShinDepartment of Food & Medical Products Regulatory Policy, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Min ParkDepartment of Bio-Pharmaceutical Industry, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Mai ZakaryaDepartment of Bio-Pharmaceutical Industry, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.
Jihong LimDepartment of Applied Life Science, Konkuk University, Chungju-si, Chungcheongbuk-do, 27478, Republic of Korea.
Kyenghee KwonDepartment of Bio-Pharmaceutical Industry, Dongguk University, Goyang-si, Gyeonggi-do, 10326, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

ChondrocyteMesenchymal stem cellsOsteoarthritisRegulationScaffold

Identifiers

PMID42859758
PMCPMC13653442

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.