Further commentary on the news from Poland
Following the widespread coverage of last week’s exciting announcement of the successful treatment of a paralysed man in Poland, Darek Fidyka, by Professor Raisman and his team using OECs (olfactory ensheathing cells), we look back on the week’s developments and answer some key questions.
We have witnessed an advance and in many ways a milestone, which is incredibly encouraging and positive. Interpreting the significance of the news is more difficult, however – if we are to continue to advance our knowledge in the right direction we need to gain a full understanding of how this patient’s functions have been affected by the procedure.
The procedure, which was a combination treatment with four elements, included a nerve graft from the ankle, injections of OECs, a surgical intervention into the spinal cord and then intensive rehabilitation. If the research field is to move forward from this point and achieve the best possible outcomes for patients, we need to understand the relative contributions of these four elements. The changes in the patient’s motor skills may have resulted from only one or several of the elements, and we need to understand the significance of each, particularly (and this is important) if a similar procedure is to be contemplated on someone with some existing function preserved. If researchers and clinicians are to build on this advance, as we surely must, it will be important to optimise the right parts of the treatment. Such questions do not slow progress but serve to enrich and accelerate it.
It is also important to remember that other treatments are in clinical trial and commercial development around the world. Some of these, like the OECs work, have been funded by Spinal Research. This is an exciting time in this field of research, offering great possibilities for people with spinal cord injury.
Giving hope is an important reason to invest in research. When Spinal Research was founded over thirty years ago, few people believed repair of the spinal cord was possible. Now, thanks to the generosity of many people and the work of many scientists, several potential treatments, including this one, are close to or in clinical trial. Within a few years, we hope they will be available to patients more widely.
We have always believed it is important to give a balanced view of research, looking at what’s really possible and when it might happen.
There are wide variations in types of spinal cord injury depending on the nature and level of injury, and in the recovery achieved through rehabilitation, with differing effects on quality of life. Potential treatments may benefit some people but not others. Equally, each person is an individual with their own priorities for rehabilitation and treatment, and their own views on research. Some people do not want to be “cured” or do not think this is likely in their case. Many recognise that any clinical treatment is still years away from general use and meanwhile the priority is getting on with life as it is now. We must also recognise that for many the news last week may have fundamentally changed these views and that places a great responsibility on those funding and reporting research; it does not lessen it.
A range of views have been expressed very cogently in the past week by people with spinal cord injury including Melanie Reid in The Times and Geoff Holt in his blog http://geoffholt.com/2014/10/paralysis-an-open-letter/
Through previous discussions we have established that patients have a range of priorities for research – not only recovery of walking and other motor skills such as hand control but also recovery of sensation and feeling, bladder and bowel control and sexual function.
Quality of life is our focus. We are keen to open up to the public our debate about what is really important to people with spinal cord injury, and how this should shape our research priorities.
We also want to be realistic about the research we fund – its potential benefits, the people it will help and how, and how long it is likely to take to get treatments into the clinic.
Will treatments become available more quickly?
The timescales for taking treatments to patients in the clinic haven’t really changed – it will take time before any therapies currently under development can be approved for wider patient use. Before the treatment given to Mr Fidyka in Poland can become a standard of care, further work needs to be done on this study, as on the other therapies currently in clinical trials.
Other treatments in clinical trial include a therapy based on Schwann cells,which speed up information flow between neurons and have a protective effect. This treatment could be beneficial for people with multiple sclerosis (MS) as well as spinal cord injury. Spinal Research supported important preclinical work by James Guest, Professor of Neurosurgery at the University of Miami, leading up to this clinical trial.
A Swiss clinical trial sponsored by StemCells, Inc. has tested human stem cells in chronic spinal cord injury patients with thoracic injuries. Neurological changes were observed and this trial is now expanding to other centres and hopes to recruit patients with cervical injuries. http://www.stemcellsinc.com/Therapeutic-Programs/Overview.htm
For a more comprehensive list of trials please visit https://clinicaltrials.gov/ and search “spinal cord injury”.
Can I go to Poland to take part in this study treatment?
The ICCP (International Campaign for Cures of spinal cord injury Paralysis) has published guidelines for patients thinking of taking part in clinical trials: http://www.spinal-research.org/wp-content/uploads/2011/09/Public-Guide-to-Experimental-Treatments-for-SCI.pdf
The OEC clinical study in Poland will be enormously useful in helping design of a larger clinical trial. However, at this time it is unclear when the group will be ready to recruit patients.
A trial would require ethical and regulatory approval, and would define the primary outcomes – such as being able to walk with a frame or crutches – which would be tested through the trial. There would be criteria for the types of patients who could be included, and some patients may be selected as a control group. The results would need to be published and peer reviewed before the global community could draw conclusions about the effectiveness of the treatment.
As with participating in any trial we recommend that anyone interested in taking part in a study or clinical trial discusses the option in detail with their own consultant / medical practitioner, who can help to advise whether participation would be in their best interests before making a decision.
What is Spinal Research doing on OECs?
What other areas of research are being supported?
A key focus for Spinal Research is our translational work which takes promising treatments from the laboratory into pre-clinical studies and towards clinical trials.
Read more here: http://www.spinal-research.org/research-matters/what-we-do/our-projects/translational-initiative/
How do we ensure a high quality of research?
We are the UK’s leading charity funding research into repair of spinal cord injury, and are currently funding research with a total value of over £4million, with more projects in the pipeline.
We are a member of the Association of Medical Research Charities (AMRC) www.amrc.org.uk and follow best practice guidelines in the selection and management of research projects. To ensure the highest quality of work, we can only fund research that is subject to peer review.
Every application for funding is rated by our Scientific Committee, which assesses the quality of science and the potential benefits to people with spinal cord injury and decides which projects can be supported within the funding available. All of our research has been approved through this system, including earlier work on OECs and many other potential treatments.
Some projects are approved for funding but unfortunately can’t be supported because funds are limited. In our last strategic funding round, ten projects were assessed as suitable for funding but we were only able to support four of these.
We are continuously fundraising to enable us to support as much promising research as possible. To help us fund more projects, please donate via our website, text SPIN41 £[amount] to 70070 or call us on 01483 898 786.
For more information about our work, please see our website or call us on 01483 898 786.