A 77 year old great-grandfather has become the first patient at Newcastle’s RVI to take part in the world’s first fully regulated clinical trial of direct stem cell therapy for strokes.
Mr Leonard McCourt – a grandfather of five and great grandfather of three – had the pioneering stem cell procedure as part of the trial, and was ready to go home just four days later.
Now in its second phase, the trial called PISCES is examining the effects of stem cell treatment, when given to people who have been left with moderate to severe neurological and limb impairments following an ischaemic stroke – where the blood supply to the brain becomes blocked.
Pioneering stem cell treatment
The hope is that the stem cell treatment will help those affected regain their independence, even with the most simple of tasks such as buttoning and unbuttoning a shirt, or feeding themselves. It could, quite literally, be life-changing.
Dr Anand Dixit, a Consultant Physician specialising in acute stroke management at the RVI, and Honorary Clinical Senior Lecturer at Newcastle University’s Institute of Cellular Medicine, says:
“There is currently very little research supporting useful intervention in patients once neurological disability has been established weeks to months after stroke. We are delighted to join the trial, as a principal participating centre for this second Phase, 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.”
Mr McCourt, a time served printer by trade, recalls what happened when he realised he had had a stroke. “I had just got back from a trip to the Coast and when I got out the car I felt a bit dizzy and wobbly. I went into the flat I lived in at the time and started to make something to eat while watching the TV.
“I suddenly realised I couldn’t work the remote with my left hand and I still felt a bit wobbly so decided to go to bed to see if I could sleep it off. When I tried to get up, I collapsed to the floor. The whole of my left side just wouldn’t work.”
Mr McCourt – a time served Printer – managed to get to his phone and dial 999. The ambulance came and luckily he had a window open so could throw the keys down to the paramedics. He was taken immediately to the RVI where tests demonstrated he had indeed suffered from a stroke.
“I was taken to Ward 41 – the Stroke Unit at the RVI – where I stayed for 3 days, and then went up to the Cherryburn Stroke Recovery Unit at the old General Hospital.”
Mr McCourt stayed on the Cherryburn Unit until the end of March this year and has made a relatively good recovery. “The left side of my body is still weak. My left arm doesn’t move which means I get fluid build-up, and I need a stick to walk – stairs are a problem.
“But I hope to get stronger and improve with time. I wouldn’t be as well recovered as I am without the terrific assistance from the Physios involved in my care – I’ve got nothing but praise from them; they are the ones that managed to get me back on my feet.”
PISCES Phase II Trial offered
After a few weeks of recovery, Mr McCourt was approached by Dr Dixit to see if he would be interested in taking part in the PISCES Phase II Trial. At first he wasn’t sure, then he made up his mind.
“I spoke to my family and then thought, ‘If all these knowledgeable people are prepared to put in all this time and effort to improving care for people like me, then so am I.”
Mr McCourt is no stranger to being in hospital. As a young lad he spent months at a time in the RVI. He had been burned quite badly in an accident and needed around 50 skin graft operations.
On this occasion, he was to be one of the first patients in the country to take part in this trial, with a view to helping stroke experts understand how to help people who have a stroke to recover their impaired movement. On his 77th birthday!
When the letter arrived with the date for the procedure, I couldn’t believe it! But again I just thought, ‘why not?’
Mr Leonard McCourt, 77 year old great grandfather who was first in the region to take part in PISCES II Trial
Dr Anand Dixit, a Consultant Physician specialising in acute stroke management at the RVI, and Honorary Clinical Senior Lecturer at Newcastle University’s Institute of Cellular Medicine, explains more about Mr McCourt’s procedure.
“Mr McCourt experienced what is known as an ischaemic stroke – ischaemic strokes occur when one of the arteries providing blood to the brain becomes blocked and this is known as an ischaemic stroke. This is the type of stroke that we are interested in for this particular clinical trial.
“Ischaemic strokes are one of the commonest types of strokes and can vary in severity. Despite recent advances in management of this type of strokes with clot busting medications or mechanical removal of clot from brain blood vessel, significant proportion of patients are left with disabling outcome. In fact, we estimate that 50% of all stroke survivors are left with permanent disabilities as a result of damage caused to brain tissue arising from this type of stroke.”
Dr Dixit, also a member of the National Hyperacute Stroke Research Collaboration continues: “Mr McCourt recovered reasonably well although he is still showing the after effects of his stroke which have left the movement in his left arm impaired and feeling numb.
“To take part in the trial, patients need to have preserved good mental function, including memory, but be experiencing significant, what we call ‘dense’ weakness. We decided after examining Mr McCourt’s test results and recovery that he was a perfect candidate for Phase II of the PISCES Trial.
“We had a chat and were delighted when Mr McCourt agreed to take part. He is an extraordinary and extremely positive gentleman.”
Specialist centre for stroke care and stem cell management
Newcastle’s Acute Stroke Unit at the RVI was specially selected to part in this pioneering trial. Not only because of its specialist expertise and ability to treat all types of strokes, but also because it is a Centre of Excellence for complex Neurosurgery and Stem Cell management. This means having the capability and setup to expertly and safely transport the stem cells from the laboratories where they are stored, to the surgical theatre.
Mr McCourt arrived at the RVI the night before his procedure and was taken into one of the Neurosurgical theatres the next morning. He had a general anaesthetic and had a temporary metal frame fitted to his head. The positioning of the frame (used for accurate injection of the stem cells) was checked using an MRI scanner. He was then taken into theatre for the procedure.
The target planning and surgery itself was carried out by Consultant Neurosurgeon, Mr Damian Holliman who has a special interest in Surgical trials for brain injury. He drilled a single small hole (1cm) hole into Mr McCourt’s skull to allow delivery of the cells for four pre-planned areas.
Mr Holliman explains: “This approach is much like keyhole surgery and so much better for the patient. Around 20 million stem cells (provided by the UK stem cell company ReNeuron) were injected directly into the affected area of the brain using an extremely fine needle. The whole procedure itself took around five hours and went smoothly.”
Mr McCourt was able to return home just four days after the procedure.
Dr Dixit says: “Mr McCourt has already said that he feels a little improvement in his left arm which is encouraging news, but we really are in the very early stages of the second phase of this trial.
“We will continue to monitor his condition over the next 3 to 12 months and eagerly await the results from the other trial sites to see how the overall picture presents over time. If this early phase of trial shows promising results in terms of feasibility, safety and signal towards improved outcomes in patients with established disability, then a further larger trial is likely to be planned with other advanced European and North American centres.
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.
