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A paper published in The Lancet established the safety of a stem cell treatment for macular degeneration after a phase 1 clinical trial.
Professor Daniel R Brison, Co-Director of the North West Embryonic Stem Cell Centre, Manchester, said:
“This is a very exciting moment for embryonic stem cell therapies. This is the first peer-reviewed scientific report showing that cells derived from human ES cells can be transplanted safely into a patient with no sign of complications. Although the study is limited to safety considerations, very small in scope, and at a very early stage, this is nonetheless a ground breaking moment for embryonic stem cell therapies. It is also very significant for the UK that the second trial of these therapies has now begun in London, only 4 months behind the US trial. These trials have used human ES cells created at research grade and this was possible as they were transplanted into the eye which is a very localised site in the body. In order to realise the full potential of ES cell therapies in the future, it will be very important to use the new generation of clinical grade ES cells now being produced in the UK.”
Professor Chris Mason, Chair of Regenerative Medicine Bioprocessing, University College London, said:
“The preliminary data on the two US patients treated using human embryonic stem cell-based therapies in June 2011 is highly encouraging, but is only the start of gathering the necessary safety data before it is possible to test if the therapy will have an impact on patients’ vision. Overall the process of testing for safety and efficacy is likely to take a minimum of 5-10 years before the potential therapy could enter routine clinical practice.
“It is not surprising that the first European human embryonic stem cell-based therapy was carried out in London, given that the UK is a world leader in cell therapy.
“The safety of embryonic stem cell-based therapies in patients is now slowly starting to emerge with both Geron data for spinal cord injury and now ACT for retinal disease. It is still a long way to go before we will have the answer as to whether embryonic stem cell-based therapies will be safe and efficacious, but progress continues to be made towards striving for the ultimate goal of life-changing therapies for patients and their carers.”
Dr Dusko Ilic, Senior Lecturer in Stem Cell Science, Kings College London, said:
“The most important thing is that Robert Lanza and his team at the Advanced Cell Technology get across a message to the media and the public that ongoing clinical trials for dry age-related macular degeneration and Stargardt’s disease with retinal pigment epithelium (RPE) derived from hES cells are safety trials. Even though in preclinical trials, the RPE were capable of extensive photoreceptor rescue in an animal model of retinal disease, resulting in improvement in visual performance without evidence of untoward pathology, we should keep in mind that people are not rats. The number one priority of initial clinical trial is always patient safety. If everyone expects that the blind patients will see after being treated with hES cell-derived RPE, even if the treatment ends up being safe (which is what Advanced Cell Technology are trying to determine in this trial), they risk being unnecessarily disappointed.”
Professor Peter Coffey, Director of the London Project to Cure Blindness, said:
“At last we are seeing the fruits of human embryonic stem cell research entering clinical trials. This will help determine the safety of these therapies. I am immensely happy that this has happened in the eye, and it can only help those patients with, until now, blinding eye diseases. Hopefully we will be able to enter our own clinical trials using embryonic stem cell therapy soon.”
‘Embryonic stem cell trials for macular degeneration: a preliminary report’ by Steven Schwartz et al. was published in The Lancet on 23rd January 2012.