ReNeuron Group has announced that its stem-cell based stroke treatment ReN001 does not form tumours, allowing it to pass major regulatory hurdles.
Pre-clinical trials, the results of which were published on November 18th, examined two rodents who had the cells implanted. One case, which has been completed, reported no tumour formation. An incomplete study has not seen evidence of anything abnormal so far.
The firm said that the ReN001 cells were derived from its c-mycER technology, which attempts to control and stop high cell growth before the stem cells are implanted.
John Sinden, CSO of ReNeuron, said the results "represent an important step forward in terms of demonstrating the ability of our c-mycER platform technology to deliver a safe and efficacious stem cell therapy for a large-scale indication, in this case our ReN001 therapy for stroke".
He added: "The findings are indicative of the power of c-mycERTAM to fully control the proliferative capacity of stem cells, a vital safety characteristic of the technology from a regulatory perspective."