As President of the Malaysian Society of Ophthalmology (MSO), I feel compelled to clarify and correct several misleading assertions made in the recent CodeBlue article published on July 4, 2025 titled “Stem Cell Breakthrough In Vision Restoration Earns Malaysian Lab Global Recognition”.
Premature Claims Of ‘Breakthrough’ And ‘Regeneration’
The article cites a single proof‑of‑concept case of Wharton’s Jelly-derived mesenchymal stem cells (WJ-MSC) restoring vision in a patient with retinitis pigmentosa (RP).
The cited article found that there was no visual improvement seen in the two patients who were treated locally. To draw a conclusion that this treatment is a ‘breakthrough’ in retinal cell ‘regeneration’ based on this result is misleading and premature.
A recent systematic review of stem cell therapy in inherited retinal diseases (RP and Stargardt) concluded there is no statistically significant, long‑term efficacy demonstrated. Improvements seen at six months tend to diminish by 12 months, and longer-term benefits remain unproven.
Although initial imaging may suggest photoreceptor change, the current consensus is that any observed effect likely reflects neuroprotection or remodeling, not true regeneration of photoreceptors.
Limited Sample Size And Lack Of Control
Valid conclusions require at least phase II/III randomised controlled trials (RCTs). To date, RP therapies using mesenchymal or progenitor cells are largely phase I or II, focusing on safety and don’t include proper control groups.
The MSO encourages clarity: ‘global recognition’ for a single-centre pilot study involving only two patients does not equate to clinical proof or guideline endorsement.
Safety And Long-Term Risks
While the article declares no adverse effects at 12 months, peer-reviewed studies report complications in other MSC trials: retinal detachment, hemorrhage, intraocular growths and even tumorogenesis in some MSC and fat-derived cell therapies.
Additionally, unsupervised, commercially driven “stem-cell tourism” has resulted in blindness and complex retinal surgery requiring emergency care.
MSO’s Position And Recommendations
- Cautious Optimism: We support ongoing research in stem cell therapies under rigorous, regulated frameworks.
- Evidence Threshold: We underscore that small trials must be followed by well-powered RCTs with objective outcomes, masked design, and long-term monitoring.
- Public Safety: Patients must be informed of all risks. Until therapies are proven, they should only be accessed via ethical and approved clinical trials.
- Regulatory Oversight: The MSO calls on the Ministry of Health and Ministry of Science, Technology and Innovation to expedite evaluation frameworks ensuring that any future therapies meet international safety and efficacy standards.
The article’s use of phrases such as ‘breakthrough’ and ‘global recognition’, and the suggestion of photoreceptor regeneration are scientifically premature.
Robust peer-reviewed literature supports MSC‑based therapy as safe in early trials, but with limited clinical evidence of lasting visual improvement.
True regenerative success in vision restoration requires pluripotent stem cell‑derived replacement of RPE or photoreceptors, and that remains under ongoing clinical investigation.
While we share optimism for emerging stem cell therapies in ophthalmology, claims of proven restoration or “breakthrough” status are untimely and unsupported.
These interventions must be evaluated through rigorous, peer-reviewed clinical trials, prioritizing patient safety and scientific validity.
This statement was issued by Prof Dr Liza Sharmini Ahmad Tajudin, president of the Malaysian Society of Ophthalmology.
- This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.