The world’s first clinical trial to use stem cells in the treatment of stroke patients has been cleared to move forward to the next phase. A review of the safety data from the ReN001 stem cell therapy trial, where stem cells were injected directly into the brains of disabled stroke patients, prompted the independent Data Safety Monitoring Board to give their stamp of approval to British biotech company ReNeuron Group PLC to move forward with additional testing at a higher dosage.The first patient to ever receive ReN001 was an elderly man who underwent the treatment last year. The therapy has been given to only two more patients since then, and data from all three patients was included in the safety assessment.
A statement from ReNeuron announced, “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.” The hope is that the stem cell injections will improve mental and physical function in patients by repairing areas damaged by stroke.
Lead researcher Keith Muir from the University of Glasgow’s Institute of Neuroscience and Psychology acknowledged that he is looking forward evaluating patients given a higher dose. He said, “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.”
Michael Hunt, ReNeuron’s chief executive, said that the approval for moving ahead marked an important milestone, and noted that the preliminary data provided support for the company’s other therapeutic programs that utilize the CTX neural stem cell line that formed the basis of ReN001.
Along with the success of the stem cell trial, comes much heated debate. Because the stem cells are derived from human fetuses rather than embryos, ethical questions are raised since the use of embryonic stem cells for research requires destruction of blastocysts formed from laboratory-fertilized human eggs. And since many people regard blastocyst as being a human life, the act is considered abortion or murder, deeming the process both immoral and unethical. However, Hunt says that the technology used to grow the cells is such that no further fetal tissue will be required.
During the next year, up to nine additional patients will receive progressively higher doses for the purposes of safety assessment. However, doctors will also be using the clinical trial data for measuring the effectiveness of the treatment for use in larger future trials.
Hunt said that at this point the development of stem cell treatments is still at an early stage and that it will take years for the treatments to become widely available. “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.”
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