The first administration to a patient in the Phase III trial of autologous skeletal muscle-derived cells (ICEF15) targeting fecal incontinence has been completed.

Innovacell K.K. (Headquarters: Shibuya, Tokyo; Representatives: Colin Lee Novick, Jason David Sieger), which aims to improve people’s health and quality of life (QOL) through cell therapy for the treatment of fecal incontinence and urinary incontinence, is pleased to announce that on September 20, the first administration to two patients in Spain has been completed in the Phase III trial using autologous myoblast-derived cell therapy product (ICEF15) targeting fecal incontinence.

This trial is a multicenter, placebo-controlled, randomized, double-blind comparative study focusing on urgent fecal incontinence, aimed at verifying and evaluating the efficacy and safety of ICEF15. Patients who meet the inclusion criteria will be allocated in a 1:1 ratio to two groups (treatment drug and placebo). The primary endpoint is the change in the frequency of fecal incontinence from baseline after 12 months of treatment.

“The first administration in the Phase III trial has taken place in Spain. I would like to express my gratitude to the patients who have chosen to participate in this clinical trial. We are planning to proceed with further administrations in Spain, as well as in Bulgaria and Sweden. We will focus on conducting the trials in each country while striving to update everyone on our progress in Japan.”

This product aims to treat urgent fecal incontinence by utilizing the patient’s own myoblasts to achieve muscle regeneration through “local administration.