ReviewRegenerative therapy2016
Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
Review in Regenerative therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 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
32 citing papers in PubMed, 60 citations in OpenAlex.
- The Need for Ethical Governance of Stem Cell Technologies in Southeast Asia.Developing world bioethics · 2026Article
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- A Reliability Tier Classification System (RTCS) for Marketed Exosome-Based Products to Facilitate Clinical Decision-Making.Clinical, cosmetic and investigational dermatology · 2026Article
- Extracellular vesicle therapeutics in Alzheimer's disease: mechanisms, progress, and prospects.Extracellular vesicles and circulating nucleic acids · 2026Review
- Exploring Regulatory Frameworks for Exosome Therapy: Insights and Perspectives.Health care science · 2025Article
- Clinical translation of human iPSC technologies: advances, safety concerns, and future directions.Frontiers in cell and developmental biology · 2025Review
- Comparative analysis of regulations and studies on stem cell therapies: focusing on induced pluripotent stem cell (iPSC)-based treatments.Stem cell research & therapy · 2024Review
- Brief summary of the regulatory frameworks of regenerative medicine therapies.Frontiers in pharmacology · 2024Review
- The occurrence and development of induced pluripotent stem cells.Frontiers in genetics · 2024Review
- A Simplified and Effective Approach for the Isolation of Small Pluripotent Stem Cells Derived from Human Peripheral Blood.Biomedicines · 2023Article
- The Exciting Realities and Possibilities of iPS-Derived Cardiomyocytes.Bioengineering (Basel, Switzerland) · 2023Review
- Merits and challenges of iPSC-derived organoids for clinical applications.Frontiers in cell and developmental biology · 2023Review
- Dental applications of induced pluripotent stem cells and their derivatives.The Japanese dental science review · 2022Review
- [Research progress of induced pluripotent stem cells in promoting wound healing of diabetic foot ulcers].Zhonghua shao shang yu chuang mian xiu fu za zhi · 2022Review
- Motor neuron replacement therapy for amyotrophic lateral sclerosis.Neural regeneration research · 2022Review
- MYCL promotes iPSC-like colony formation via MYC Box 0 and 2 domains.Scientific reports · 2021Article
- Stem cell translational medicine: The Tianjin model revisited.Stem cells translational medicine · 2021Article
- Principles for establishment of the stem cell bank and its applications on management of sports injuries.Stem cell research & therapy · 2021Review
- Cell Therapy: Types, Regulation, and Clinical Benefits.Frontiers in medicine · 2021Review
- Regenerative medicine for the upper gastrointestinal tract.Regenerative therapy · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In Japan, a research center network consisting of Kyoto University to provide clinical-grade induced Pluripotent Stem Cells (iPSC) and several major research centers to develop iPSC-based regenerative therapies was formed for the clinical application of iPSCs. This network is under the supervision of a newly formed funding agency, the Japan Agency for Medical Research and Development. In parallel, regulatory authorities of Japan, including the Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, are trying to accelerate the development process of regenerative medicine products (RMPs) by several initiatives: 1) introduction of a conditional and time-limited approval scheme only applicable to RMPs under the revised Pharmaceuticals and Medical Devices Act, 2) expansion of a consultation program at the early stage of development, 3) establishment of guidelines to support efficient development and review and 4) enhancement of post-market safety measures such as introduction of patient registries and setting user requirements with cooperation from relevant academic societies and experts. Ultimately, the establishment of a global network among iPSC banks that derives clinical-grade iPSCs from human leukocyte antigens homozygous donors has been proposed. In order to share clinical-grade iPSCs globally and to facilitate global development of iPSC-based RMPs, it will be necessary to promote regulatory harmonization and to establish common standards related to iPSCs and differentiated cells based on scientific evidence.
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.