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The trial, announced by the Geron corporation in the United States, will test a treatment for spinal injuries based on injecting spinal cells grown from embryonic stem cells into patients paralysed from chest down. The trial, the first of its kind to be approved in the US, will open the way for similar trials to take place in the UK.
Professor Chris Mason, Professor of Regenerative Medicine at University College London, said:
“This historic decision by the FDA is a pivotal milestone in the development of embryonic stem cell therapies. The knowledge that will be gained in this first clinical trial deploying embryonic stem cell derived material will accelerated the development of all future stem cell therapies. This decision is therefore very encouraging news for patients, carers and healthcare providers such as the NHS. The FDA must be congratulated on their pragmatic approach to these advanced new therapies.”
Professor Pete Coffey, Director of the London Project to Cure Blindness , said:
“This is bloody good news. It’s great news for the field and shows that there is a regulatory procedure for Embryonic Cells to follow. I would guess, and I hope, that this will encourage business to invest in stem cell therapies especially if Geron’s share price has gone up after this morning’s announcement. This strengthens our recent call for regulators in the UK to help provide a clear process for researchers to take this forward. It’s also exciting for me because it brings our own moves towards clinical trials with embryonic stem cells for age-related macular degeneration a step forward.”
Prof Robin Lovell-Badge, Head of Division, MRC National Institute for Medical Research, said:
“I am often asked why there are still no treatments derived from human embryonic stem cells ? Geron’s experience provides the answer. It takes many years of careful work to develop a therapy, often 15-20; Geron had access very early on to the first cell lines about ten years ago. It takes a long time and much work to derive processes that will efficiently and reproducibly give an appropriate cell type for grafting and many animal experiments to test efficacy and safety. An appropriate set of patients have to be identified for the first tests and clinicians willing to participate in trials. And the regulatory hurdle is, understandably, a huge one: in this case it required 21,000 pages of documents. Moreover, everyone is nervous. No one wants any trial to go wrong, but if it is the first then there is a fear that even minor problems could set back the field. It wasn’t always like this – the first heart transplants were a disaster, but now they are almost routine. We are now in a far more cautious age. Nevertheless, for those patients desperate for treatment, and for their families, this news shows that the research is moving in the right direction. The time it takes is unfortunately just a critical side-effect of the process of developing a bone-fide treatment.”