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A number of UK stem cell and medical experts offered their thoughts on the ending of Geron’s clinical trial of stem cell therapy for spinal cord injury.
Prof Charles ffrench-Constant, Director at the University of Edinburgh’s MRC Centre for Regenerative Medicine, said:
“In prioritising their anti-cancer drugs over stem cell based products, Geron’s decision illustrates the difficulties and costs of bringing stem cell based therapies to the clinic. They have however made enormous advances in defining the various issues that need to be considered for stem cell therapies, advances that will be of huge value to others in the field. It is important to note that their decision reflects current commercial pressure, and does not point to any issues over their current trials in stem cell transplants as treatment for spinal cord injury. It does, however, clearly illustrate the value of the proposed Technology Innovation Centre in Cell Therapy to be funded by the UK Government via the Technology Strategy Board in finding ways to reduce costs and lower barriers to accelerate these promising therapies to the patient.”
Azim Surani, Marshall-Walton Professor, University of Cambridge, said:
“Stem cell-based therapy is not the only end point of research in this field. Indeed, this research can contribute in multiple ways to advances in medicine. For example, stem cells provide the basis for building excellent disease models in culture that can mimic events leading to diseases in adults. Using such models, it is possible to develop new therapeutic agents to prevent or cure diseases. Above all, from such studies we gain fundamental knowledge which can provide the foundation for applications in ways that are not always predictable as has often been shown in the past.”
Professor Joyce Tait, ESRC Innogen Centre, University of Edinburgh, said:
“Regulatory demands, both cost and time, are a major – but rarely specified – factor in company decisions to pull out of a cell therapy at various stages of its development. As with most innovation at the cutting edge of the life sciences, cell therapies will be subject to the costly and lengthy regulatory requirements that have evolved in the context of the blockbuster pharmaceutical drug pipeline. Until recently profit margins on new drugs have been high enough to cope with the regulatory costs, but early cell therapies are likely to be niche market products, at least in the early stages of marketing.
“This means that at present small to medium sized companies are incapable of taking a product from initial concept to a viable market. Regulatory agencies are aware of this problem, and are making efforts to move therapies through the still-evolving regulatory systems in the EU and USA. But this does not yet lower the time and cost barriers enough to allow products like cell therapies to make it all the way to a viable, profitable market. The Innogen Centre’s research[1] points to the need to re-think regulatory systems across the board, from cell therapies to pharmaceuticals and stratified medicine. 21st century regulatory systems are needed for 21st century science in order to reap the benefits of basic science that is publicly funded.”
Dr Dusko Ilic, Senior Lecturer in Stem Cell Science at King’s College London, said:
“Geron is a pioneer in the stem cell business and it is very disappointing to see that the Company has had to change direction after years of being on top of the game. The decision was obviously made for financial reasons. But the public will need reassurance that this is not the end of an era. To keep hope alive, governments and the private sector will have to demonstrate confidence in stem cell research by continuous investment in a new generation of research that will move science forward and translate discoveries into reliable clinical outcomes.”
Professor Alison Murdoch, Head of Newcastle Fertility Centre at Life, Newcastle University, said:
“Making superman walk would have been great for business but was an ambitious target for a serious problem and maybe not the best start scientifically or clinically for stem cell therapies.”
Professor Anthony Hollander, Arthritis Research UK Professor of Rheumatology and Tissue Engineering, University of Bristol, said:
“Getting the business case right is as important as getting the science right for each stem cell therapy that we develop.”
John Martin, professor of cardiovascular medicine at UCL , said:
“I have said publicly that the Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back.
“The first trials of stem cell that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.”
Ben Sykes, Executive Director, UK National Stem Cell Network, said:
“Stem cell research continues to show great promise in helping many people currently suffering from incurable conditions and injuries. It is disappointing that Geron has taken the decision to stop its spinal cord injury trial but we hope that the company is able to find new partners who can take on the work and provide the necessary finance. It is important to remember that the development of stem cell-based therapies is still in its early stages and, under difficult economic circumstances, companies are occasionally forced to prioritise other therapies which are more developed. It remains hugely expensive to bring any new medicine or therapy to the clinic, and failure rates can be high, particularly in later-stage clinical trials. It is entirely clear that the decision is based on business reasons and not on the results achieved in their clinical trial so far.”