ArticleHealth care science2025
Exploring Regulatory Frameworks for Exosome Therapy: Insights and Perspectives.
Article in Health care science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled 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.
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
34 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Use of Microneedling With Exosomes in Dermatology: A Systematic Review.Journal of cosmetic dermatology · 2026Pooled it
- A product control framework for extracellular vesicle therapeutics: Quality attributes, stability, analytical procedures, and biodistribution.International journal of pharmaceutics: X · 2026Review
- Exosome and biotherapeutic strategies for dermatological and oncological skin complications.Annals of medicine · 2026Review
- Hit the bull's eye: Engineered extracellular vesicles for targeted therapy.Bioactive materials · 2026Review
- Review
- Engineering extracellular vesicle biogenesis for therapeutic gene delivery: emerging genetic programming strategies and translational prospects.Molecular biology reports · 2026Review
- Regulatory Challenges and Opportunities for Cell-Derived Extracellular Vesicles in Pharmaceutical Development: A European and Global Perspective.Journal of extracellular vesicles · 2026Review
- Mesenchymal Stem Cells and Extracellular Vesicles: Bridging the Translational Gap in Regenerative Medicine.International journal of molecular sciences · 2026Article
- Chemotherapeutic Loading and Delivery of Patient-Derived Extracellular Vesicles Are Influenced by Colorectal Cancer Disease Stage and Protein Corona.Pharmaceutics · 2026Article
- Recent progress of plant-derived extracellular vesicle-like nanoparticles integrated with biomaterials for skin repair.Journal of nanobiotechnology · 2026Review
- Exosomes as Disease-Informed Nanoplatforms for Pulmonary Fibrosis: From Pathogenic Signaling to Precision Diagnosis and Therapy.Pharmaceutics · 2026Review
- Review
- Glycolysis-driven cancer-associated fibroblasts shape T-Cell exclusion via the CXCL16-CXCR6 Axis: a metabolic-chemokine mechanism in tumor immunity.Journal of translational medicine · 2026Review
- Vaccine Adjuvants and Delivery Systems: A Comprehensive Review.International journal of molecular sciences · 2026Review
- Beyond Extracellular Vesicle (EV) Hype: Practical Solutions and Remaining Hurdles in EV Research, Manufacturing, and Clinical Translation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Extracellular Vesicles in Allergy: From Cellular Communication to Clinical Implications.Clinical reviews in allergy & immunology · 2026Review
- Plant-derived nanocarriers & nanostructures for barrier-defined translation: a comprehensive review of mechanisms, targets, and translation.Journal of nanobiotechnology · 2026Review
- Regulatory, ethical, and clinical barriers to exosome use in interventional pain medicine.Interventional pain medicine · 2026Article
- Therapeutic applications of mesenchymal stem cell-derived extracellular vesicles in pain management: A narrative review of emerging evidence and future directions.World journal of stem cells · 2026Review
- Global Research Trends in Extracellular Vesicle-Based Therapy for Regenerative Medicine: A Bibliometric Analysis (2014-2024).Bioengineering (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Extracellular vesicles (EVs) have emerged as a promising technology for diagnostic and therapeutic applications in clinical settings over the past decade. However, their advancement is hindered by complex technological and regulatory challenges. This review outlines key considerations in the manufacturing process, quality management, and nonclinical evaluation relevant to EV-based drug development. Furthermore, we summarize and compare technical regulatory requirements across major countries to help clarify the regulatory principles governing EV products. Our analysis reveals an ongoing international debate regarding the regulatory review of EVs. Nevertheless, adopting a risk-based classification framework that categorizes EV products as advanced therapeutic drugs is a rational approach. Critical challenges include the development of standardized production protocols, a clearer understanding of therapeutic mechanisms, and resolving complex regulatory issues.
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.