Evidence map›Paper›PMID 41732694›Full record

ArticleRegenerative therapy2026

Regulatory insights on adeno-associated virus-based gene therapies, cell- and tissue-based products, and CAR-T cell therapies: report from the 8th Asia Partnership Conference of Regenerative Medicine, April 24, 2025.

Shunsuke Tominaga, Yoshie Tsurumaki, Yusuke Kagawa, Aki Kito, Masaaki Miyano, Kazuhiro Ooka, Srinivasan N Kellathur, Shigeaki Hayashi, Masayuki Nomura

Abstract read
PubMed Full text at PMC Publisher
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

9 authors.

Shunsuke TominagaNovartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan.
Yoshie TsurumakiHELIOS K.K., 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.
Yusuke KagawaNovartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan.
Aki KitoChugai Pharmaceutical Co., Ltd., 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo, 103-8324, Japan.
Masaaki MiyanoChugai Pharmaceutical Co., Ltd., 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo, 103-8324, Japan.
Kazuhiro OokaGilead Sciences K.K., 9-2, Marunouchi 1-chome, Chiyoda-ku, Tokyo, 100-6814, Japan.
Srinivasan N KellathurRoche Singapore Technical Operations, #10-01/09 Aperia Tower 1, 8 Kallang Avenue, 339509, Singapore.
Shigeaki HayashiJapan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi, 443-0022, Japan.
Masayuki NomuraAsahi Kasei Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 8th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in a hybrid format-both in person and online-on April 24, 2025, to advance regulatory harmonization for regenerative medicine products across Asia. Understanding the domestic regulatory guidelines and their underlying rationales within each country and region represents a crucial first step toward achieving harmonized regulation. The 8th APACRM featured open discussions and case study presentations addressing the Quality by Design (QbD) approach in gene therapy manufacturing, non-clinical evaluation of adeno-associated virus (AAV)-based gene therapy products, the product lifecycle and regulatory landscape of AAV gene therapies, and post-launch regulatory requirements for regenerative medical products. The program included presentations by industry experts and panel discussions with representatives from regulatory agencies. The latest national and regional updates on regenerative medicine were also shared. This paper summarizes the proceedings of the 8th APACRM to facilitate future dialogue and promote the dissemination of regulatory information across the field.

Indexed as

Adeno-associated virus-based gene therapiesAPACRMAsiaCell and gene therapy productsCell and tissue-based productsClinicalNon-clinicalRegulatory guideline

Identifiers

PMID41732694
PMCPMC12925219

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.