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Updated: Jan 19, 2026
Development of a Refined Protocol for Trans-scleral Subretinal Transplantation of Human Retinal Pigment Epithelial Cells into Rat Eyes
Published on: August 12, 2017
Retinal stem cell transplantation: Balancing safety and potential
Mandeep S Singh1, Susanna S Park2, Thomas A Albini3
1Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Abstract:
Stem cell transplantation holds great promise as a potential treatment for currently incurable retinal degenerative diseases that cause poor vision and blindness. Recently, safety data have emerged from several Phase I/II clinical trials of retinal stem cell transplantation. These clinical trials, usually run in partnership with academic institutions, are based on sound preclinical studies and are focused on patient safety. However, reports of serious adverse events arising from cell therapy in other poorly regulated centers have now emerged in the lay and scientific press. While progress in stem cell research for blindness has been greeted with great enthusiasm by patients, scientists, doctors and industry alike, these adverse events have raised concerns about the safety of retinal stem cell transplantation and whether patients are truly protected from undue harm. The aim of this review is to summarize and appraise the safety of human retinal stem cell transplantation in the context of its potential to be developed into an effective treatment for retinal degenerative diseases.
Insights
Human retinal stem cell transplantation shows promise for treating blindness. This review appraises safety data from clinical trials, addressing concerns from adverse events in poorly regulated centers.
Area of Science:
- Ophthalmology
- Regenerative Medicine
- Cell Therapy
Background:
- Retinal degenerative diseases cause vision loss and blindness.
- Stem cell transplantation is a promising therapeutic approach.
- Concerns exist regarding the safety of retinal stem cell transplantation due to reported adverse events.
Purpose of the Study:
- To review and evaluate the safety of human retinal stem cell transplantation.
- To assess the potential of this therapy for treating retinal degenerative diseases.
Main Methods:
- Systematic review of safety data from Phase I/II clinical trials.
- Appraisal of preclinical studies underpinning clinical trials.
- Analysis of reported adverse events in the scientific and lay press.
Main Results:
- Phase I/II clinical trials, often in academic partnerships, focus on patient safety.
- Unregulated centers have reported serious adverse events associated with cell therapy.
- Safety data from regulated trials are crucial for patient protection.
Conclusions:
- Human retinal stem cell transplantation requires rigorous safety evaluation.
- Ensuring patient safety is paramount for the clinical development of this therapy.
- Further research is needed to establish the safety profile for treating retinal degenerative diseases.
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