ArticleCell reports. Medicine2025
A first-in-human clinical study of an allogenic iPSC-derived corneal endothelial cell substitute transplantation for bullous keratopathy.
Article in Cell reports. Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed.
- Genetically engineered hypoimmunogenic iPSCs: Strategies and considerations for clinical applications.Regenerative therapy · 2026Review
- Induced pluripotent stem cells from discovery to translation.Nature medicine · 2026Review
- Induced Pluripotent Stem Cells in Corneal Regeneration: Biological Progress, Translational Barriers and Clinical Outlook.Biomedicines · 2026Review
- Metabolic and redox adaptations of the corneal endothelium: From metabolic plasticity to therapeutic opportunities.Redox biology · 2026Review
- Structure Variations and 3D Genome Disruption: Implications in Safety of hPSC-Based Cell Therapy.International journal of molecular sciences · 2026Review
- Long-Term Endothelial Outcomes and Dislocation Risks in Small Versus Large Grafts for Descemet's Stripping Endothelial Keratoplasty.Medical science monitor : international medical journal of experimental and clinical research · 2026Article
- High-Purity Functional Corneal Endothelial Cells From Human Induced Pluripotent Stem Cells via a Novel Wash-Out Method.MedComm · 2026Article
- Engineering BiTE-inspired IPSC-exosomes to potentiate CAR-T cell therapy against lung cancer.Journal of nanobiotechnology · 2026Article
- Review
- Injectable corneal endothelial cell therapy: recent progress, translational barriers, and future directions.Frontiers in ophthalmology · 2026Review
- Artificial intelligence in corneal endothelial disease and endothelial keratoplasty: current evidence, clinical readiness, and future directions.Frontiers in ophthalmology · 2026Review
- Current Landscape and Future Prospects of Corneal Regenerative Medicine.Ophthalmology and therapy · 2026Review
- Review
- Direct in vivo reprogramming to relieve tissue ischemia via induced vasculogenesis.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Bioengineering Strategies for Corneal Endothelial Cell Injection Therapy: Advances, Challenges, and Clinical Translation.Bioengineering (Basel, Switzerland) · 2025Review
- RhoKinase (ROCK) Inhibition as a Therapeutic Strategy for Pseudophakic Bullous Keratopathy: A Comprehensive Review.Journal of clinical medicine · 2025Review
- Clinical Applications of Corneal Cells Derived from Induced Pluripotent Stem Cells.Biomolecules · 2025Review
- Developing stem cells for corneal disease: recent developments and future perspectives.Regenerative medicine · 2025Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A first-in-human investigator-initiated clinical study of a corneal endothelial cell substitute (CLS001) derived from a clinical-grade induced pluripotent stem cell (iPSC) line shows improvement of visual acuity and corneal stromal edema, with no adverse events for up to 1 year after surgery for the treatment of bullous keratopathy. While preclinical tests, including multiple whole-genome analysis and tumorigenicity tests adhering to the Food and Drug Administration (FDA) draft guidelines, are negative, an additional whole-genome analysis conducted on transplanted CLS001 cells reveals a de novo in-frame deletion of exon22 in the EP300 gene. No adverse events related to the mutation are observed. Our study demonstrates the feasibility of using iPSC-derived cells to replace donor transplant for bullous keratopathy, while shedding light on risk management of gene mutation in cell products. Further follow-up is required for long-term analysis of clinical safety and efficacy.
Indexed as
Identifiers
What Socratic 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 Socratic graph.