First patient treated in groundbreaking stem cell trial
pharmafile | November 16, 2010 | News story | Research and Development | GRNOPC1, Geron, PISCES, Pilot Investigation of Stem Cells in Stroke, ReN001, ReNeuron, Stem cells, ischaemic stroke, stroke
The first patient has been treated in a groundbreaking stem cell trial as part of a bid to develop a new therapy for stroke victims.
Guildford, UK-based ReNeuron Group’s ReN001 cells were administered to a patient at the Institute of Neurological Sciences at Glasgow’s Southern General, who was then safely discharged.
PISCES (Pilot Investigation of Stem Cells in Stroke) is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients.
The phase I study is primarily designed to test ReN001’s safety in ischaemic stroke – the most common kind, caused by a blockage of blood flow in the brain – at a range of cell doses.
Twelve patients will receive it between 6 and 24 months after their stroke: pre-clinical studies of ReN001 in rats have shown the therapy helped to reverse some stroke disability, even though it was administered several weeks after a stroke occuring.
At present, ischaemic stroke is treated by anti-clotting agents in the acute phase of the condition, but relatively few patients get to hospital in time to receive them.
ReNeuron says a number of efficacy measures will also be evaluated over the course of the trial, with patients monitored for two years.
“We are seeking to establish the safety and feasibility of stem cell implantation,” explained principal investigator Professor Keith Muir, from the Division of Clinical Neurosciences at the University of Glasgow.
He said the study would require “careful follow-up”. If the Data Safety Monitoring Board is satisfied with the first patient’s progress next month, the rest of the trial’s first dose cohort in the trial will be treated.
“We hope that in future it will lead on to larger studies to determine the effects of stem cells on the disabilities that result from stroke,” added Muir.
UK Stroke Association estimates that 150,000 people suffer a stroke in the UK each year, half of whom are left with permanent disabilities as a result of the damage caused to brain tissue.
The annual health and social costs of caring for these patients is estimated to be in excess of £5 billion in the UK.
While it is nascent technology, there is great interest in stem cells as potential therapies.
In August US regulator the FDA gave California-based Geron Corporation the green light to restart the world’s first phase I trial of any stem cell therapy.
The firm is now treating patients with spinal cord injury using GRNOPC1, which contains human embryonic stem cells (hESC)-derived oligodendrocyte progenitor cells.
It had been stopped by the FDA after nine months when a pre-clinical trial showed a higher frequency of test animals developed cysts at the injury site than had been noted in earlier studies.
Adam Hill
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