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expert reaction to first clinical trial of human embryonic stem cell-based therapy in patients with spinal cord injury

An American patient paralysed by a spinal cord injury has become the first person to be treated with embryonic stem cells, as part of a clinical trial run by the US biotechnology company Geron.

 

Prof Robin Lovell Badge, Head of Genetics at the MRC’s National Institute of Medical Research, said:

“It has taken a lot of time and a huge effort from Geron and their associated scientists and clinicians to get to this stage, namely the first clinical trial based on cells derived from human Embryonic Stem cells. In this case it is to treat patients with severe spinal cord injuries. We hope the treatment will prove to be safe and really wish that it will show some benefit, as indicated by the preceeding experiments in animals. However, the trial has been set up to look for problems and if these arise then hopefully those involved will still at least learn how to do better next time.

“Everyone, including the patients, their doctors and the scientists, have to be brave in this first attempt, otherwise no progress can be made. The first attempts at heart transplants did not go at all well, but now they are an accepted part of clinical treatment. Back then society was much less risk adverse than now, but the risks for something going wrong in this trial could be viewed as being important to the whole endeavour, not just to the patients. If it works, there will hopefully be far fewer critics of research on human Embryonic Stem cells especially in the USA. If it does not, the critics will no doubt be rejoicing, but they will be foolish to do so. Other trials will follow soon, for a range of clinical problems – and even if just one works well, it will all be worthwhile.”

 

Colin Blakemore, Professor of Neuroscience, University of Oxford and Former Chief Executive of the Medical Research Council, said:

“The FDA’s decision to allow this trial to proceed is an indication of the changed attitude to stem cell research in the United States. Massive funding is now being injected into such research there. It would be sad if the UK, which has led the world in high-quality, ethically sound research in this field, were now to cut funding, while the rest of the world is able to make the long-term investment needed to continue such important research and transform it into new treatments for patients.”

 

David Bott, Director of Innovation Programmes, Technology Strategy Board, said:

“This is exactly the sort a of application that will use stem cells first – extreme trauma, patients looking for miracle! It will still be some time before they reach the mass market, but without this sort of pilot, we will not make progress. An important step, but only a step.”

 

Professor Sir Ian Wilmut, Director, MRC Centre for Regenerative Medicine, University of Edinburgh, said:

“This is very exciting news, however, it is very important to appreciate that the objective of Trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits. Once that has been confirmed then the focus moves on to development and assessment of the new treatment.”

 

Professor Chris Mason, Chair of Regenerative Medicine Bioprocessing, Advanced Centre for Biochemical Engineering, University College London, said:

“This first in man study marks the dawn of the ‘Stem Cell Age’. The essential transition, from bench to bedside, is a critical step-change in the progression of embryonic stem cells towards eventual cures. There are still many years of rigorous testing ahead and no doubt there will be set backs and failures before we have safe and effective cell-based therapies. This pivotal clinical trial is a major morale boost for scientists, clinicians and most of all patients by finally commencing the transformation of stem cells from a scientific curiosity into advanced healthcare.”

 

Ben Sykes, Executive Director, UK National Stem Cell Network, said:

“This is indeed a significant milestone in our journey towards the promise of stem cell-based medicines. Geron’s commitment to reaching this first stage of phased clinical trials has been rewarded with the first full regulatory approval – at least in the Western world – to proceed with a human embryonic stem cell-based therapy in a human patient. The global stem cell and regenerative medicine community will be awaiting the results of this safety trial with much anticipation.”

 

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