Evidence map›Paper›PMID 40276700›Full record

ReviewRegenerative therapy2025

Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024.

Yoshie Tsurumaki, Yusuke Kagawa, Shigeaki Hayashi, Hirokuni Mizoguchi, Masaaki Miyano, Masaki Fujii, Ruriko Shinozaki, Srinivasan N Kellathur, Alex J Zhang, Kunihiko Suzuki and 1 more

Abstract readReview
In one paragraph

Review in Regenerative therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

11 authors.

Yoshie TsurumakiNovartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan.
Yusuke KagawaNovartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan.
Shigeaki HayashiJapan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi, 443-0022, Japan.
Hirokuni MizoguchiAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Tokyo, Japan.
Masaaki MiyanoChugai Pharmaceutical Co., Ltd., 5-1, Ukima 5-Chome, Kita-ku, Tokyo, 115-8543, Japan.
Masaki FujiiMitsui-Soko HOLDINGS Co., Ltd., 20-1 Nishi-Shimbashi 3-chome, Minato-ku, Tokyo, 105-0003, Japan.
Ruriko ShinozakiAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Tokyo, Japan.
Srinivasan N KellathurRoche Singapore Technical Operations, #10-01/09 Aperia Tower 1, 8 Kallang Avenue, Singapore, 339509, Singapore.
Alex J ZhangHELP Therapeutics Co., Ltd., 568 Longmian Avenue, Jiangning District, Nanjing, PR China.
Kunihiko SuzukiMEDINET Co., Ltd., 6-1-1 Heiwajima, Ota-ku, Tokyo, 143-0006, 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 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of cell and gene therapies as medical practices without market authorization. These discussions included presentations by industry experts and panel discussions with regulatory agencies. The latest updates on regenerative medicine from each country and region were also introduced. This paper summarizes the proceedings of the 7th APACRM to foster future discussions and disseminate information to the public.

Indexed as

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

Identifiers

PMID40276700
PMCPMC12019077

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.