May 28, 2013
Stem Cell Trial Leads To ‘Mild To Moderate’ Improvement In Stroke Patients
redOrbit Staff & Wire Reports - Your Universe Online
More than half of the seriously disabled stroke victims participating in preliminary clinical trials of a new stem cell procedure have shown modest signs of recovery, the scientists carrying out the research reported Monday.According to Sam Marsden of The Telegraph, five out of the nine ischemic stroke patients taking part in the PISCES trial were able to regain some movement in their hands and legs after undergoing the procedure, in which stem cells were injected directly into the damaged parts of their brains.
The patients showed “mild to moderate” improvement in their conditions after receiving injections of the ReNeuron Group´s ReN001 stem cell therapy, Marsden explained. “Some of the patients were able to move their fingers again after several years of complete paralysis, while others found that they could walk around their houses by themselves without assistance,” he added.
Glasgow University professor Keith Muir, who is treating the patients, told BBC News Science Correspondent Pallab Ghosh that he was “surprised” by the amount of recovery in the patients. However, he also emphasized that it was too soon to determine whether or not the stem cell treatment is responsible for their partial recovery.
The results, which were presented by Muir at the European Stroke Conference in London on Monday, demonstrate that there have been no adverse side effects observed in the patients to this point. The beneficial effects, though, could be attributed to the close medical attention being given to the patients and not the treatment itself, Ghosh said.
“It is well documented that the feeling of wellbeing resulting from such attention, known as the placebo effect, can have a positive effect on people's health,” the BBC News reporter said. “But it is thought that stroke patients do not recover after the first six months of their stroke. All the patients involved in the trial had their strokes between six months and five years before they received the treatment.”
The PISCES trial is nearing its end, the university said, and full results will be published sometime in 2014. In the meantime, plans are underway for a Phase II trial designed to investigate the efficacy of stem cell treatment in stroke patients.
The Phase II trial would be a controlled multi-facility trial involving approximately 20 patients, all of whom would have suffered a stroke just a few weeks before starting treatment. An application is expected to be submitted to UK regulatory agencies in early July, and if approved, the trial would begin later this year.
“We remain pleased and encouraged by the data emerging from the PISCES study. The data to date identify no safety issues with the ReN001 treatment — which is the primary focus of this Phase I trial,” Muir said in a statement. “The evidence of functional improvement requires further investigation in a suitably designed Phase II efficacy study and we look forward to being a principal clinical site in that study when it commences.”
“The PISCES study continues to yield encouraging results,” added Michael Hunt, Chief Executive Officer of ReNeuron. “Assuming the remaining required short-term follow up data confirm the good safety profile of the treatment, we will be able to move the ReN001 therapy confidently into Phase II clinical development, as planned, later this year.”