ArticleStem cells translational medicine2020
Preclinical safety studies of human embryonic stem cell-derived retinal pigment epithelial cells for the treatment of age-related macular degeneration.
Article in Stem cells translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Review
- Establishment of human embryonic stem cell line expressing EGFP reporter driven by human RAX promoter for evaluation of retinal progenitor cell potency.In vitro cellular & developmental biology. Animal · 2026Article
- Advances in Stem Cell Therapies for Ocular Diseases: Progress in Clinical Trials and Future Perspectives.Stem cell reviews and reports · 2025Review
- Safety Assessment of Stem Cell-Based Therapies: Current Standards and Advancing Frameworks.Cells · 2025Review
- Transplantation of human embryonic stem cell-derived retinal pigment epithelial cells via injectable microfluidic-templated microgels for retinal regeneration.Materials today. Bio · 2025Article
- Allogeneic RPE cell suspension manufactured at scale demonstrating preclinical safety and efficacy led to IND approval.NPJ Regenerative medicine · 2025Article
- Advances in the Study of Age-Related Macular Degeneration Based on Cell or Cell-Biomaterial Scaffolds.Bioengineering (Basel, Switzerland) · 2025Review
- Stem cell therapies for neurological disorders: current progress, challenges, and future perspectives.European journal of medical research · 2024Review
- Crosstalk Between Microglia and Müller Glia in the Age-Related Macular Degeneration: Role and Therapeutic Value of Neuroinflammation.Aging and disease · 2024Review
- Human and Pig Pluripotent Stem Cells: From Cellular Products to Organogenesis and Beyond.Cells · 2023Review
- Advances in cell therapies using stem cells/progenitors as a novel approach for neurovascular repair of the diabetic retina.Stem cell research & therapy · 2022Review
- Efficient differentiation of human embryonic stem cells to retinal pigment epithelium under defined conditions.Stem cell research & therapy · 2021Article
- Stem Cell Therapy for Retinal Degeneration: The Evidence to Date.Biologics : targets & therapy · 2021Review
- Preclinical safety studies of human embryonic stem cell-derived retinal pigment epithelial cells for the treatment of age-related macular degeneration.Stem cells translational medicine · 2020Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As pluripotent stem cell (PSC)-based reparative cell therapies are reaching the bedside, there is a growing need for the standardization of studies concerning safety of the derived products. Clinical trials using these promising strategies are in development, and treatment for age-related macular degeneration is one of the first that has reached patients. We have previously established a xeno-free and defined differentiation protocol to generate functional human embryonic stem cells (hESCs)-derived retinal pigment epithelial (RPE) cells. In this study, we perform preclinical safety studies including karyotype and whole-genome sequencing (WGS) to assess genome stability, single-cell RNA sequencing to ensure cell purity, and biodistribution and tumorigenicity analysis to rule out potential migratory or tumorigenic properties of these cells. WGS analysis illustrates that existing germline variants load is higher than the introduced variants acquired through in vitro culture or differentiation, and enforces the importance to examine the genome integrity at a deeper level than just karyotype. Altogether, we provide a strategy for preclinical evaluation of PSC-based therapies and the data support safety of the hESC-RPE cells generated through our in vitro differentiation methodology.
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