Green light for stem cell study
15.08.2012 - The British stem cell specialist ReNeuron has received the go-ahead for its phase I trial with disabled stroke patients.
After having reviewed the safety data from the first two dose cohorts, the Data Safety Monitoring Board (DSMB) has recommended to continue the PISCES trial with ReN001. ReNeuron’s ReN001 cell therapy for stroke consists of a neural stem cell line. Until now, no adverse side effects have been found in the review period. Six patients have been included in the trial, the first 18 months ago. “We are delighted that the DSMB have given a favourable recommendation to proceed to the higher and penultimate dose in the PISCES stroke trial,” said ReNeuron’s chief executive Michael Hunt. The study is testing the safety and tolerability of the treatment of ascending doses of the ReN001 cells in patients with moderate to severe functional neurological impairments from their strokes in what is the world’s first fully regulated clinical trial. In June this year, the firm revealed that the first five PISCES patients showed reductions in neurological impairment and spasticity. These improvements were sustained in the longer-term. If everything goes on as planned, ReNeuron could apply for a phase II study in 2013.