ReNeuron Group Plc (LON:RENE) has recruited all of the patients for its phase II trial of its CTX stem cell treatment for motor disability in stroke victims.
Three-month follow-up data is expected to be available in the fourth quarter of this year.
Ahead of this, ReNeuron has commenced the regulatory process for a Phase II/III clinical trial for CTX in stroke disability with US Food and Drug Administration.
Similar discussions are taking place with the equivalent European regulatory body, the European Medicines Agency (EMA).
Subject to the results of the Phase II study, the company expects to file an application in the first quarter of 2017 to commence a Phase II/III clinical trial.
ReNeuron added that it appointed a sales team in Japan after changes in regulations that allow conditional marketing approval for cell therapies at an earlier stage of clinical development than in the West.
It will seek talks with regulatory authorities in Japan to see how CTX is affected by the new regulations.
Olav Hellebø, Reneuron’s chief executive said: "The completion of patient recruitment in the PISCES II study in stroke disability marks another important step in the clinical development of our CTX cell therapy candidate for this condition.
“We are making good progress in planning the Phase II/III study, which we expect to be an international controlled study with patient recruitment in both Europe and the US."