The UK's ReNeuron has been given a regulatory green light to launch the world's first human trial of a stem cell therapy for strokes.
Beginning in the second quarter of this year, researchers for the biotech will begin to see exactly how stroke victims respond to the neural stem cell therapy, which researchers say could help significantly repair brain damage. The UK Gene Therapy Advisory Committee granted approval of the trial--five years after ReNeuron first approached officials in Europe. The Financial Times notes that the company later tried to get the FDA on board to test the therapy, but regulators in the U.S. repeatedly delayed the process.
"This final approval represents the culmination of many months of work in taking our ReN001 therapy through a regulatory process in the UK largely untested by other stem cell therapy approaches of this type," said Michael Hunt, ReNeuron's chief executive. "We are therefore pleased to have in many ways pioneered that regulatory pathway for subsequent cell therapy applications."
The trial will enroll patients who have been left disabled by ischemic stroke.
- here's the ReNeuron release
- and here's the story from The Financial Times