Evidence map›Paper›PMID 40654517›Full record

ReviewRegenerative therapy2025

Basic Points to Consider for Cell Storage under the Act on the Safety of Regenerative Medicine in Japan.

Yuki Uno, Kazuaki Nakamura, Morikuni Tobita, Manabu Mizutani, Masatoki Watanabe, Kosuke Kawai, Masahiro Kino-Oka

Abstract readReview
PubMed Full text at PMC Publisher
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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Yuki UnoDepartment of Biotechnology, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.
Kazuaki NakamuraDepartment of Pharmacology, National Research Institute for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 157-8535, Japan.
Morikuni TobitaMedical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Manabu MizutaniResearch Base for Cell Manufacturability, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.
Masatoki WatanabeJapan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori-shi, Aichi, 443-0022, Japan.
Kosuke KawaiIwatani Corporation, 6-4 Hommachi 3-chome, Chuo-ku, Osaka-shi, Osaka, 541-0053, Japan.
Masahiro Kino-OkaDepartment of Biotechnology, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Regenerative medicine is an emerging field of medical treatment characterized by numerous uncertainties, necessitating regulatory frameworks that ensure both patient safety and timely clinical application. Among the three legislative measures established in Japan to facilitate the safety and efficient implementation of regenerative medicine, the Act on the Safety of Regenerative Medicine (RM Safety Act) governs regenerative medicine and cell therapies (RMTs) that utilize processed cells without manufacturing and marketing authorization. These therapies are conducted either as non-commercial clinical trials or as out-of-pocket therapies at the discretion of medical practitioners. More than a decade has passed since the enactment of the RM Safety Act, during which various aspects of RMTs have been clarified. The Evaluation Committee on Regenerative Medicine, Health Sciences Council, published the

Indexed as

Act on the Safety of Regenerative MedicineCell storageCell therapyCryopreservationRegenerative medicineRegulation

Identifiers

PMID40654517
PMCPMC12246579

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.