Stroke experts in Newcastle are set to be amongst the first in the UK to take part in the second phase of a pioneering clinical trial testing the effects of stem cell treatment for patients who have experienced a stroke.
The clinical trial called PISCES is the world’s first fully regulated clinical trial programme of direct stem cell therapy for strokes.
Strokes are the third largest cause of death, and single largest cause of adult disability in the developed world.
Phase II of the PISCES trial follows on from the successful first phase carried out in 2013. The PISCES Phase I trial looked at the safety and tolerability of the new therapy when given to a small number of patients with moderate to severe neurological and limb impairments following an ischaemic stroke – where the blood supply to the brain is blocked by a blood clot.
The results of Phase I were promising with findings that no cell related adverse effects occurred up to two years after implantation, and that the treatment was well tolerated.
Dr Anand Dixit to lead clinical trial in Newcastle
Dr Anand Dixit, a Consultant Physician specialising in acute stroke management at the city’s Royal Victoria Infirmary, and Honorary Clinical Senior Lecturer at Newcastle University will lead the trial in Newcastle. He says:
“I, together with my colleagues in Newcastle, have been following Phase I of the PISCES trial with great interest. Professor Keith Muir, Principal Investigator of the study from the University of Glasgow recently visited the North East to report on his findings. To hear the evidence first hand was incredibly encouraging and we are delighted to join the trial, taking the studies to the next stage as a principal participating centre for Phase II.”
“As was the case during Phase I, PISCES II will involve a single injection of CTX cells into a stroke patient’s brain. This is done under anaesthetic and most patients stay in hospital for one to 2 days after treatment. Since the first PISCES study concerned safety, people were selected for stability and then underwent the intervention between six months and five years after their stroke.
Patients to be approached one to nine months after stroke
Dr Dixit adds: “In the current trial, patients will be approached one to nine months after the stroke, since it is believed that earlier intervention, during the period of natural recovery, is likely to be optimal to test whether stem cell therapy is effective*. Each patient will then be monitored regularly for one year after receiving the treatment”
* The only current, effective treatment for ischaemic stroke patients takes place within hours of the stroke occurring (known as the acute phase), when clot dissolving agents are given to restore the blood flow to the brain.
We are hopeful that we are stepping closer to being able to introduce a ground-breaking new treatment.
Dr Anand Dixit, Consultant physician specialising in acute stroke management at Newcastle's RVI
Newcastle Hospitals have also been part of mechanical clot retrieval studies whereby clot in the blood vessel is removed with the help of stent which helps enhance action of clot busting medications.
Dr Dixit, a member of the National Hyperacute Stroke Research Collaboration continues: “There is very little research supporting useful intervention in patients once neurological disability has been established weeks to months after stroke. We will continue to closely monitor the outcomes of PISCES II and are hopeful that we are stepping closer to being able to introduce a ground-breaking new treatment which could offer some degree of recovery of function for disabled stroke patients.”
Newcastle’s stroke experts have previously been at the forefront of leading stroke research and devised F.A.S.T. – the Face Arm Speech Test which was developed for stroke recognition. This has been rolled out nationally as a stroke assessment tool used by paramedics.
Stroke
Approximately 150,000 people suffer a stroke in the UK each year. The vast majority (80%) of these are ischaemic in nature, caused by a blockage of blood flow in the brain (as opposed to a haemorrhagic or bleeding stroke). This new stem cell treatment under development only relates to ischaemic stroke.
It is estimated that one half of all stroke survivors are left with permanent disabilities as a result of the damage caused to brain tissue arising from the stroke. Depending on the part of the brain affected, people who have had a stroke may experience difficulties with speech and language, orientation and movement, or memory. These problems can be permanent or temporary.
The PISCES Clinical Trial
The PISCES Study is the world’s first clinical trial of a neural stem cell therapy for stroke patients. The Phase I trial was designed to look at whether the use of the experimental treatment (ReN001 therapy) was safe and tolerable and only involved nine patients. This type of study precedes trials of effectiveness (Phase II).
PISCES II will see the CTX stem therapy evaluated as part of a UK multi-site clinical trial. The study has been adopted by the NHS National Institute for Health Research Stroke Research Network (SRN).
The trial will involve up to 41 patients split into two cohorts. The first cohort will treat 21 patients. If two or more patients from the 21 meet meaningful improvement criteria six months after treatment, up to 20 additional patients will be treated in a second cohort.
ReNeuron’s CTX stem cell therapy
The CTX stem cells therapy for stroke consists of a neural stem cell line generated using cell selection technologies produced by ReNeuron – a leading UK based stem cell therapy company.
Stem cells
Stem cells are the very early cells that develop into almost all other types of cells in the body such as the skin, muscle or blood cells. They are the building blocks of the body and are unique because they can renew themselves. They also have the ability to form different specialised cell types.
There is currently a great deal of medical research looking into the potential for harnessing the regenerating power of stem cells to repair damaged tissue and fight disease.
