ReviewStem cell reports2021
Reflection on the enactment and impact of safety laws for regenerative medicine in Japan.
Review in Stem cell reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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.
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.
Who cites it
10 citing papers in PubMed.
- New legal category of 'advanced regenerative medicine treatment' in Korea's amended regenerative medicine law: comparative lessons from Japan.Stem cell reports · 2026Article
- Stem Cell Therapy for Inflammatory Diseases: Progress, Challenges, and Future Directions.MedComm · 2026Review
- Basic Points to Consider for Cell Storage under the Act on the Safety of Regenerative Medicine in Japan.Regenerative therapy · 2025Review
- Combinatorial intervention with dental pulp stem cells and sulfasalazine in a rat model of ulcerative colitis.Inflammopharmacology · 2024Article
- The advancement of artificial intelligence in biomedical research and health innovation: challenges and opportunities in emerging economies.Globalization and health · 2024Review
- Brief summary of the regulatory frameworks of regenerative medicine therapies.Frontiers in pharmacology · 2024Review
- Manufacturing clinical-grade human induced pluripotent stem cell-derived beta cells for diabetes treatment.Cell proliferation · 2022Review
- Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan.Stem cell reports · 2022Article
- Regenerative Medicine in South Korea: Bridging the Gap Between Authorization and Reimbursement.Frontiers in bioengineering and biotechnology · 2021Article
- Perspectives on Challenges to Cell Therapy Development in Taiwan: Strengthening Evidential Standards and Ways Forward.Frontiers in bioengineering and biotechnology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.