Researchers have started the world’s first clinical trial of stem cells to treat stroke victims in Glasgow. The trial is undertaken by ReNeuron, a Guildford-based biotech company and started this weekend with an elderly man receiving an injection of 2 million stem cells into his brain. It received final approval to go ahead this year.
The team is led by Professor Keith Muir of neuroscience at Glasgow University at the Southern General Hospital in the city which treated the unnamed patient over the weekend. He has now been allowed to return home. Laurence Dunn, a neurosurgeon, successfully injected the stem cells into the patient.
Professor Muir said, “We are pleased that the first patient has undergone surgery successfully… In this trial, we are seeking to establish the safety and feasibility of stem cell implantation, which will require careful follow-up of the patients who take part.” He added that if this first patient continues to do well over the next few weeks, a further 11 people who have been disabled by stroke will be treated over the next year. The volunteers, all from the South Glasgow area, will be treated with progressively higher doses of ReNeuron’s neural stem cells. The final patients will receive injections of 20 million cells. Clinicians will be monitoring the patients for signs that the stem cells are repairing their brains and improving their condition as is shown in animal experiments.
These cells are derived originally from aborted human fetuses and are manufactured for ReNeuron by Angel Biotechnology in Edinburgh. These fetal stem cells are different from the embryonic stem cells being used by Geron, a larger biotech company, for a clinical trial to treat spinal injury in the US. The latter are derived from human embryos at an earlier stage of development. Assuaging ethical qualms ReNeuron said that no new fetal cells will be required in future for its stroke therapy and all future requirements can be met by multiplying cells from its existing stock.
Independent stem cell specialists all over the world are eagerly awaiting results. Anthony Hollander, professor of tissue engineering at the University of Bristol, said: “It’s far too early to know if the treatment will be successful but the very fact that the trial is now under way is a milestone for UK stem cell research.”
John Sinden, chief scientific officer at ReNeuron, the Surrey-based company said about the first patient, “He is really looking for some level of independence.” Citing animal studies he said, “We see regrowth of blood vessels, the generation of new neurons, a reduction in scarring and inflammation in the brain…There are a range of things that happen that are best described as the brain to some extent healing itself.”
The study is named the Pilot Investigation of Stem Cells in Stroke (PISCES) study.
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