UK-based company ReNeuron Group has crossed the final approval hurdle to taking ReN001, its stem cell therapy for stroke, into patients in its home market.

ReNeuron expects to start patient recruitment and evaluation for the first-in-human trial this April. It said the UK Gene Therapy Advisory Committee (GTAC) had given a “full and final Favourable Opinion” to the study, the first ever worldwide to use expanded neural stem cells in stroke patients.

The company recently secured regulatory approval for the trial from the Medicines and Healthcare products Regulatory Agency (MHRA). The GTAC acts as the national research ethics committee for clinical trials with gene therapies and stem cell therapies in the UK.

The ReN001 trial will be conducted through the National Health Service at the Institute of Neurological Sciences in Greater Glasgow, Scotland and the Clyde NHS Board. The therapy will be administered to patients left disabled by an ischaemic stroke – primarily to test ReN001’s safety profile at a range of cell doses, although a number of efficacy measures will also be evaluated over the course of the trial.

Participants will be monitored for two years, with longer-term follow-up procedures after that. If the early patient cohorts deliver satisfactory safety data, ReNeuron intends to pursue an accelerated clinical development programme with ReN001, focusing initially on more severely disabled stroke patients.

£6 million regenerative medicine funds

ReNeuron’s announcement came just after the Technology Strategy Board, the arm’s length public body established by the UK government in 2007 and sponsored by the Department for Business, Innovation and Skills, said it was putting another £6 million into research and development projects in regenerative medicine.

The investment is part of a £21.5 million programme of competitions for regenerative medicine projects launched by the Technology Strategy Board last September.

Out of the £6 million, up to £4 million will go on a Developing Therapeutics competition, which will enable UK businesses to pursue preclinical and clinical development of regenerative medicine therapies. Up to £2 million is available for Tools and Technologies Feasibility Studies in areas such as assessing the safety and/or efficacy of regenerative medicine therapies, or developing robust and reproducible manufacturing processes.

Both competitions will open on 8 March 2010 and British companies are invited to bid for funding.