ReviewStem cell reports2023
Country-specific regulation and international standardization of cell-based therapeutic products derived from pluripotent stem cells.
Review 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 20 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
20 citing papers in PubMed.
- Coarse-graining analysis for non-invasive, label-free, and quantitative evaluation of undulating motion in cultured oral mucosa epithelial cell sheets.Regenerative therapy · 2026Article
- Allogeneic islet products for type 1 diabetes: Navigating nonclinical and manufacturing regulatory expectations.Stem cell reports · 2026Review
- Article
- Stem Cells and Their Derivatives in Cardiac Fibrosis Therapy: Challenges and Perspectives.Cells · 2026Review
- Global clinical trial landscape of stem cell-based therapies for osteoarthritis: trends and translational implications.Frontiers in cell and developmental biology · 2026Article
- Novel developments in retinal regeneration: Advances and future outlooks in stem cell therapy.World journal of stem cells · 2025Review
- Safety Assessment of Stem Cell-Based Therapies: Current Standards and Advancing Frameworks.Cells · 2025Review
- Preclinical quality, safety, and efficacy of a CGMP iPSC-derived myogenic progenitor product for the treatment of muscular dystrophies.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Extracorporeal Photopheresis: Does It Have a Potential Place Among Cell-based Therapies?Transplantation direct · 2025Article
- Clinical Applications of Corneal Cells Derived from Induced Pluripotent Stem Cells.Biomolecules · 2025Review
- The Collapse of Brain Clearance: Glymphatic-Venous Failure, Aquaporin-4 Breakdown, and AI-Empowered Precision Neurotherapeutics in Intracranial Hypertension.International journal of molecular sciences · 2025Review
- Sustainable Innovations in Food Microbiology: Fermentation, Biocontrol, and Functional Foods.Foods (Basel, Switzerland) · 2025Review
- Guidance on the clinical application of extracellular vesicles.Regenerative therapy · 2025Review
- Surveying local CAR T-cell manufacturing processes to facilitate standardization and expand accessibility.Journal of translational medicine · 2025Article
- Targeted animal models for preclinical assessment of cellular and gene therapies in pancreatic and liver diseases: regulatory and practical insights.Cytotherapy · 2025Review
- Clinical translation of human iPSC technologies: advances, safety concerns, and future directions.Frontiers in cell and developmental biology · 2025Review
- Harnessing cellular therapeutics for type 1 diabetes mellitus: progress, challenges, and the road ahead.Nature reviews. Endocrinology · 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
- Detection of residual pluripotent stem cells in cell therapy products utilizing droplet digital PCR: an international multisite evaluation study.Stem cells translational medicine · 2024Article
- Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges.Signal transduction and targeted therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Currently, many types of cell-based therapeutic products (CTPs) derived from pluripotent stem cells (PSCs) are being developed in a lot of countries, some of which are in clinical trial stages. CTPs are classified differently in different countries and regions. The evaluation of their efficacy, safety, and quality also differs from that for conventional small-molecule drugs and biopharmaceuticals, which reflects the complex properties of living cells and unmet medical needs. Since there are no international guidelines to evaluate CTPs, including PSC-derived products, it is necessary to be aware of differences in relevant laws and regulations in different countries and regions. International consortia are organized and actively working to standardize/harmonize the evaluation methods and regulations to facilitate the development and global distribution of PSC-derived CTPs. In this paper, we outline the regulations related to PSC-derived CTPs in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use founding regions (US, EU/UK, Japan) and introduce representative consortia working on their standardization.
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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.