British clinical researchers have just received regulatory approval and will soon be able start the first ever clinical investigation that will use brain-derived stem cells in the treatment of stroke. The treatment will involve grafting
“different doses of cultured human neural stem cells grafted into the brains of patients who have had a stroke.” It is hoped that the stem cell transplant can repair or regenerate brain cells damaged during a stroke.
The Phase I trial will initially investigate the safety of the treatment, which is normal for the different steps of conducting clinical trials. Only when the treatment has been proven to be safe, can its efficacy for the indication involved be investigated. Previous studies using stem cells didn’t have any promising results. Previously, stem cells transplants used were derived from an embryonic tumor, which raised concerns about induction of tumor development in the human brain.
The currently tested treatment uses “expanded neural stem cells” developed by the UK biotech company ReNeuron. The ReN00a stem cell therapy has been developed specifically for transplant. The cells have been isolated from human embryonic cells, and then modified by the addition of a gene that promotes cell growth. This helps them to divide in culture in the lab so they can be grown up into the vast numbers required for the trial.
According the ReNeuron:
“The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. The ReN001 cells will be administered by direct injection into the affected region of the brain in a straightforward surgical procedure. Importantly, the nature of the procedure and the characteristics of the ReN001 cells mean that the patients will not require immunosuppression following treatment, thus eliminating the safety risks typically associated with immunosuppression regimens. Patients in the trial will be monitored for one year, with longer term follow-up procedures in place thereafter.”
The trial will be conducted at the Institute of Neurological Sciences, Southern General Hospital in Glasgow and will be coordinated by the neurologist Dr. Keith Muir of the University of Glasgow. Twelve stroke patients will be the first to be enrolled in the study.
According to Dr. Muir:
“Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke. We are very excited at the opportunity to undertake this, the first clinical trial involving neural stem cell therapy in stroke. At this stage, we are primarily seeking to establish the safety and feasibility of this form of treatment, and if successful, we hope that it will lead on to larger studies looking at the effects of the treatment on patient recovery.”
We are definitely crossing our fingers.
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