Concerned about patients accessing stem-cell treatments for eye conditions that have not been subjected to appropriate clinical trials and approvals, the Royal Australian and New Zealand College of Ophthalmologists and Stem Cells Australia, have joined up to launch an informative patient-information leaflet for people considering such treatments.
For a new stem-cell treatment, patients are advised to ensure it is part of an ethically-approved clinical trial.
The patient-information resource is designed to help patients make more-informed decisions about their eye care by encouraging them to ask five important questions about stem cells for eyesight before undergoing any form of stem cell treatment for ocular disease:
- What are stem cells and how can they help?
- What are the safety concerns?
- Is there evidence that stem cell therapies work?
- Stem cell treatments are still under investigation, so what does that mean for me?
- How can I make an informed decision about my options?
Locally and internationally stem cell research is at the cutting edge and is attracting media attention. A recent Washington Post article, highlighted the fact that clinics are emerging offering high-risk procedures that are not yet scientifically proven:
RANZCO initiated the position paper identifying a role in guiding the Australian and New Zealand public around discriminating between evidence-based treatments and those that have not yet been proven to be safe and effective.
Evidence of the harmful consequences that can result from such treatments, including loss of vision, has been published in medical journals, including a recent article in the New England Journal of Medicine.
RANZCO formed a working group of stem cell experts who collaborated with SCA
RANZCO formed a working group of stem cell experts who collaborated with SCA to develop the position statement and patient information brochure.
There was an urgent need for the RANZCO and Stem Cells Australia to develop the Stem Cells for Eyesight leaflet and the RANZCO position statement as patients have gone blind overseas from stem cell treatments. The disastrous results of a stem cell treatment for macular degeneration using cells obtained from liposuction were reported in the New England Journal of Medicine and were highlighted by the New York Times and Washington Post. The patients who lost sight, incorrectly thought they were participating in government-approved research having seen a study by the clinic advertised on the government clinical trials website.
In Australia there have been recent increases in demand for and availability of stem cell treatments. Although clinical trials are underway and some are delivering promising results, not all treatments are supported by evidence in terms of safety and quality. Further clinical testing over a longer period of time across a larger patient sample is needed to better establish safety and effectiveness.
‘Potendtial for treating a range of ocular conditions .. just beginning to understand’
Professor Stephanie Watson, of RANZCO, and chair of the Ophthalmic Research Institute of Australia and professor at the Save Sight Institute, University of Sydney, explains: “The potential of stem cells for treating a range of ocular disease is really very exciting. We are just beginning to understand what might be achievable and in the future we may have cures for eye conditions that are thought of as incurable today.
“That is all thanks to the research that is happening now. However, more research is required before we know the full impact of these treatments and how safe they are over the longer term. For that reason, we recommend that people only take part in clinical trials that have ethics approval and meet the standards of Australia’s regulatory body, the Therapeutic Goods Administration.
“Approved clinical trials will be registered on the Australian and New Zealand Clinical Trials Registry and will monitor patients over time to assess the long-term safety and outcomes of treatment. Patients should ensure that treatments have been tested thoroughly in clinical trials and long term outcomes data is collected.”
Associate Professor Megan Munsie from Stem Cells Australia and deputy director of the University of Melbourne’s Centre for Stem Cell Systems added: “We hope that our new resource can help patients and their families make more informed choices.
“Unfortunately for too long commercial stem cell clinics operating outside mainstream medicine have made inflated and simplistic claims about ways to restore or save vision. While they may use the language of science, what’s offered by these clinics is effectively a trade in hope.
“We need to draw a greater distinction between legitimate stem cell research and commercial exploitation. Our new resource helps guide patients in their research and hopefully inform discussions with their treating ophthalmologist.