Stem-cell brain jab for stroke patients clears safety hurdle

Researchers at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow have already injected the early stage neural cells into the brains of three stroke patients in a world-first trial.

After passing safety tests, they have now been given the go-ahead to give more patients even bigger doses of the stem cells.

While it is hoped that they will eventually be able to show that the stem cells help repair damaged brain tissue and reduce disability, so far the focus has been on showing no harmful effects in the patients given the injections.

The research has now been given clearance by the Data Safety Monitoring Board (DSMB), which oversees such work, so patients can be given doses of the product – known as ReN001 – containing more than double the number of stem cells administered to volunteers so far.

It is hoped three more patients can be treated this year with the higher doses, with a further three getting even more cells next year as part of the Pilot Investigation of Stem Cells in Stroke (PISCES) trial.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world, making the search for new treatments a key priority for scientists.

Around 13,000 people a year suffer strokes in Scotland, 3,000 of them aged under-65.

Lead researcher Professor Keith Muir, from the Institute of Neuroscience and psychology at Glasgow University, said: “We are pleased that there have been no safety issues from the first dose cohort in the PISCES trial and we look forward to evaluating further patients at a 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.”

Asked if the researchers had seen any improvement in the patients already treated, Prof Muir said: “At this stage it is really safety we are concerned with.

“We are looking closely at possible changes in people and it is very difficult to conclude anything with much confidence.

“The patients are very different in terms of the extent and severity of the strokes they have had, and we are also operating in an area where we don’t really know what the effect of sticking a needle into someone’s brain after a stroke is and we have the added issue that, understandably, people are rather anxious about having these procedures.

“So we are probably not assessing them in the run-up period when they are completely normal, so any changes we have seen after the procedure might just be relief that they are still alive let alone anything to do with the cells.

“We have seen some interesting things along the way but it is far too early to conclude that we have anything that indicates an effect of them.”

Prof Muir said they did not yet know what level of dose might be needed to have an effect, and it may be that lower doses could be the most effective.

The ReN001 therapy has been created by the company ReNeuron following previous trials in the laboratory.

Michael Hunt, chief executive of ReNeuron, said: “We are delighted that the DSMB have given a favourable recommendation to proceed to a higher dose in the PISCES stroke trial. This represents an important milestone for the trial.”

Prof Muir is set to present further data on the trial at the Stroke Association’s Sixth UK Stroke Forum Conference in Glasgow, which starts in November.