Evidence map›Paper›PMID 37977143›Full record

ArticleStem cell reports2023

Does the Act on the Safety of Regenerative Medicine in Japan ensure "safety"?: Implications of low adverse event reporting.

Tsunakuni Ikka, Taichi Hatta, Yoko Saito, Misao Fujita

Abstract readLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cell reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Amendment ofRegenerative therapy · 2025
    Review
  3. Article
  4. 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

4 authors.

Tsunakuni IkkaDivision of Bioethics & Healthcare Law, Institute for Cancer Control, National Cancer Center Japan, Chuo-ku, Tokyo 104-0045, Japan; Division of Bioethics, Center for Research Administration and Support, National Cancer Center Japan, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: tikka@ncc.go.jp.
Taichi HattaGraduate School of Public Health, Shizuoka Graduate University of Public Health, Aoi-ku, Shizuoka 420-0881, Japan. Electronic address: thatta@s-sph.ac.jp.
Yoko SaitoDivision of Bioethics, Center for Research Administration and Support, National Cancer Center Japan, Chuo-ku, Tokyo 104-0045, Japan.
Misao FujitaUehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University, Sakyo-ku, Kyoto 606-8507, Japan; Institute for the Advanced Study of Human Biology (WPI-ASHBi), KUIAS, Kyoto University, Sakyo-ku, Kyoto 606-8501, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Public document analysis reveals that the adverse events reported for therapeutic administration under the Act on the Safety of Regenerative Medicine (ASRM) in Japan are substantially fewer than those under the Pharmaceuticals and Medical Devices Act. This study highlights the flawed reporting mechanisms and unmet legislative intentions of the ASRM.

Indexed as

Regenerative MedicineJapan

Identifiers

PMID37977143
PMCPMC10724052

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.