In the first trial to use stem cell therapy in stroke patients, five of the nine people treated have shown unexpected partial recovery from their disabilities. 'We've seen people who now have the ability to move their fingers where they have had several years of complete paralysis', lead researcher Professor Keith Muir from the University of Glasgow told the BBC.
The patients, treated at Glasgow's Southern General Hospital, had previously shown no signs of spontaneous improvement following their strokes. 80-year-old Frank Marsh, told the BBC: 'I can now grip things that I couldn't grip before, like the hand rails at the swimming baths'.
Caused by a lack of blood to a part of the brain, stroke can cause severe, lasting damage. Trial participants received an injection of neural stem cells directly into the damaged area of their brains. As stem cells retain the able to multiply and develop into a variety of mature cell types, it is hoped they could limit or reverse any damage to the brain cells of stroke victims.
Announced at the recent European Stroke Conference, researchers revealed the interim findings of the ongoing Pilot Investigation of Stem Cells in Stroke (PISCES) trial. As a phase I clinical trial, this study is designed to assess the safety of the procedure on a small number of people. 'We remain pleased and encouraged by the data emerging from the PISCES study. The data to date identify no safety issues with the [stem cell] treatment', said Professor Muir.
While encouraging, the success of these five patients is not enough to prove that the therapy is causing the partial recoveries. Only larger trials with more patients and correct controls can establish whether the treatment is genuinely working, and that improvements are not just due to the placebo effect.
The neural stem cell line used was developed by ReNeuron – who sponsored the trial – and had previously been shown to improve symptoms in rats. There is some opposition from anti-abortion campaigners to the use of these cells, as they were originally derived from a human fetus sample.
The team plan to seek approval for a phase II trial when they submit the updated findings of the trial in early July, and hope to begin recruitment for a second trial shortly after.