Long-term data from the PISCES II trial earlier this year showed the treatment has the potential to improve the disability of stroke patients.
PISCES III – as this next study will be called – will be much bigger, recruiting 110 patients across 25 sites in the US.
It will compare how many patients treated with either the CTX therapy or a placebo demonstrate a “clinically important improvement” on the Modified Rankin Scale – a measure of disability and dependence.
Data from the study is expected towards the end of 2019.
"We are delighted to have received regulatory approval to commence our first clinical trial in the US with our CTX cell therapy candidate for stroke disability,” said chief executive Olav Hellebø.
“No therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients.
“This important clinical trial represents a further step towards potentially meeting that very significant unmet need and we look forward to initiating the study during the first half of next year.”
Progress made in first half
Thursday’s approval caps off a productive six months for the cell-based therapeutics specialist, during which it also started dosing patients in the phase II element of the ongoing phase I/II clinical trial of its hRPC stem cell therapy candidate for retinitis pigmentosa.
A phase II trial of hRPC in the degenerative eye disease is due to get underway in the middle of 2018, alongside a phase II study in cone rod dystrophy.
Elsewhere, pre-clinical data of ReNeuron’s ExoPr0 exosome therapy candidate also showed it may have a “significant effect” in regulating cell growth and reducing cancer cell proliferation.
The company also thinks it could be used to target “multiple” other diseases but for the time being it will focus on cancer, and an initial clinical trial application is planned for 2019.
ReNeuron recorded a loss of £9.6mln (2016: loss of £7.7mln) for the six months through to September 30
At the end of the period the AIM-quoted group had £45.3mln of cash and cash equivalents (31 March: £53.1mln).
“During the period, our therapeutic development programmes have continued to progress to plan,” added Hellebø.
“This progress positions us for the delivery of further significant clinical milestones across our therapeutic programmes during each of the next three years.”