September 1, 2011
UK Brain Stem Cell Trial To Move Forward
The first-of-its-kind clinical trial to inject stem cells into the brains of people disabled from stroke has been cleared to move on to the next phase after the treatment was found to pose no significant safety concerns in the first three patients in the study.
“We need to be assured of safety before we can progress to trying to test the effects of this therapy. Because this is the first time this type of cell therapy has been used in humans, it's vitally important that we determine that it's safe to proceed - so at the present time we have the clearance to proceed to the next higher dose of cells,” said Muir.
ReNeuron Group PLC, the British firm behind the trial, said the Data Safety Monitoring Board (DSMB) had reviewed the ReN001 stem cell therapy data and made the recommendations to move forward with a higher dose.
“Data from the laboratory safety tests, neurological examinations and neurofunctional tests conducted thus far indicate that the ReN001 treatment is safe and well-tolerated at the initial dose,” ReNeuron said in a statement on Thursday.
An elderly man became the first person to receive the pioneering treatment last year. Since then it has been tried on two more patients.
Each patient received very low doses of stem cells in trials designed to test the safety of the procedure.
Now that ReNeuron has the go-ahead, it plans to test the therapy on up to nine more patients over the coming year. These patients will receive progressively higher dosages, allowing researchers to continue to monitor and assess safety. If this next phase is a success, the team hopes to conduct larger trials in 18 months.
The procedure involves injecting neural stem cells into patients´ brains with the hope they will repair areas damaged by stroke, thereby improving both mental and physical function. It uses stem cells derived from human fetuses rather than embryos.
Professor Muir said he looked forward to evaluating further patients using the higher dose. “ReN001 has the potential to address a very significant unmet medical need in disabled stroke patients and I am pleased that our team is involved in this pioneering clinical trial,” he told BBC News.
ReNeuron´s CEO Michael Hunt said the clearance to move forward is a milestone for the landmark therapy.
“The earliest a treatment could be widely available if everything goes very well is five years. It is very much a case of so far, so good. It is still at a very early stage but we draw great comfort from these results,” Hunt added.
Analysts at Matrix said ReNeuron was making excellent progress and believe the trial could set the research firm apart from other stem-cell companies in the field, given the advantages it has in terms of manufacturing, scalability and the off-the-shelf nature of the technology.
“The data generated thus far are all the more remarkable, in our view, given the fact that the patients receiving the cells have not been subject to immunosuppression,” they said in a note to Reuters. “We look forward to the data from the next cohort within this study.”
The Stroke Association estimates that strokes kill about 67,000 people every year in the UK. It says stroke is the third most common cause of death in England and Wales after heart disease and cancer.
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