ReNeuron has been given final UK regulatory and ethical clearance to start two new clinical trials assessing stem-cell therapies in stroke and critical limb ischaemia (CLI).

The UK group said the green light has been given to kick off a Phase II clinical trial in stroke disability, recruiting up to 41 patients and treating eight-12 weeks post-stroke, which is thought to be the optimum treatment window for efficacy.

The trial will assess ReN001, an investigational therapy for disabled stroke patients, at NHS hospital trusts throughout the UK, monitoring a number of validated stroke efficacy measures up to six months post-treatment.

The study is expected to read out by the end of 2015.

A separate Phase I trial is designed to investigate ReN009 in CLI,  a common condition in patients with diabetes that can lead to amputation of the affected limb.  

In preclinical studies, ReN009 therapy has shown the potential to restore sufficient blood flow in the affected lower limb to avoid amputation, and the associated health consequences.

This dose-escalation trial will be carried out through NHS Tayside at Ninewells Hospital and Medical School, Dundee, Scotland, with patients to be monitored for up to 12 months to assess the treatment's safety and tolerability.

Assuming a good short term safety profile for ReN009 at its highest dose, ReNeuron said it expects to file for approval to start a Phase II efficacy study during the first half of 2015.