Innovacell received regulatory clearance from the U.S. FDA to include American clinical sites and patients in its ongoing Phase III global clinical trial, according to a Tokyo bourse filing on Thursday.

The study evaluates ICEF15, an advanced cell therapy candidate designed as a less invasive, potentially curative treatment for patients suffering from urge fecal incontinence.

The placebo-controlled trial is already actively enrolling patients across Japan and 11 European countries to evaluate the treatment's long-term efficacy and safety.

With the majority of the global enrollment target already met, the company has begun preparing multiple U.S. sites to help finalize patient recruitment by the end of the year.