The UK's ReNeuron Group is signaling that it is ready to move on from a lengthy and so far fruitless attempt to get the FDA to approve a Phase I trial in the U.S. using fetal stem cells to replace damaged brain tissue in permanently disabled stroke victims. After discussions that have dragged on more than a year, says ReNeuron, the FDA is still seeking more information on ReN001 and the request is likely to take at least a few months to work out. As a result, they're shifting their focus to other (unnamed) countries where regulators have indicated that they are likely to give researchers the green light ReNeuron is looking for.
"We now deem it prudent to accelerate the process of filing clinical trial applications for ReN001 in certain other territories where discussions with the relevant regulators have given us high confidence that such applications will be treated favorably," the company said in a statement. "Our principal near-term goal remains to drive the ReN001 programme into its clinical phase in a well-regulated territory at the earliest opportunity. We are confident of achieving that goal over the course of this year."
- read the press release for more info
ReNeuron looks to resolve FDA issues. Report
ReNeuron confident of trial OK. Report
Stem cells demonstrate ability to repair brain damage. Report