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Don’t risk your sight: beware of dodgy clinical trials and treatments

News from the United States of three women paying US$5000 each for an unproven and unregulated stem cell treatment for their macular degeneration – and being seriously harmed in the process – underscores the need for all clinical trials to be thoroughly scrutinized and approved.

A detailed report of the incident was published in The New England Journal of Medicine.

“The potential benefits of stem cell research to combat eye diseases and other conditions is well-known but this hopeful avenue of discovery could be undermined by bogus ‘treatments’ as described in this recent case,” said Associate Professor Alice Pébay of the Centre for Eye Research Australia (CERA).

Of concern is that two of the women mistakenly thought they were participating in a research project that was being overseen by Government, which it was not. Furthermore, the administration of cells into the eye was not done by specialist eye doctors.

CERA conducts clinical studies for many eye conditions including: diabetic eye disease, age-related macular degeneration, glaucoma, uveitis, dry eye, and other retinal diseases.

“All our studies have been grounded in extensive preclinical research work which includes assessments of safety. All research is approved by the Ethics Committee of the Royal Victorian Eye and Ear Hospital, and I would urge anyone interested in participating in a trial to consult our website as a first step,” said Associate Professor Pébay.

CERA is currently running more than 20 clinical studies, involving over 300 patients ranging from smaller studies initiated by our research teams, to global multi-site studies in collaboration with pharmaceutical companies.

The study teams comprise of registered ophthalmologists, study coordinators (most of whom are eye health professionals) and nurses and have expertise in state-of-the-art clinical trials research and research governance.

“Our teams are passionate about research and patient care. By participating in clinical studies, participants can contribute to advancing health and medical knowledge with the confidence that the research is being performed at world-best standards,” said Associate Professor Lyndell Lim, Head, CERA’s Clinical Trials Research Centre.

“What was reported in the U.S is an extremely unfortunate episode and points to the need for careful oversight and a robust research program prior to clinical translation,” said Associate Professor Lim.

Find out more about stem-cell research.