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

Innovacell K.K. (Headquarters: Shinagawa, Tokyo; Representatives: Colin Lee Novick, CEO, and Jason David Sieger, COO) aims to improve health and quality of life (QOL) through cell therapy for the treatment of fecal and urinary incontinence. We are pleased to announce that on December 14, the administration to the first patient in Japan using our cell therapy product, ICEF15, derived from autologous myoblasts for the treatment of fecal incontinence, has been successfully completed.

This trial is a multi-center, placebo-controlled, randomized, double-blind comparison study targeting urgent fecal incontinence, designed to verify and evaluate the efficacy and safety of ICEF15. Patients who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to two groups (treatment and placebo). The primary endpoint is the change in fecal incontinence frequency from baseline to 12 months after administration.

I am very pleased and relieved to announce the completion of the first administration in the Phase III trial in Japan before the end of the year. First and foremost, I would like to express my gratitude to the patients who have decided to participate in this trial. Additionally, I would like to take this opportunity to thank everyone who has worked hard to bring us to this day, especially in light of the challenges posed by the COVID-19 pandemic.

A very big “Thank you!” and “Otsukaresama” to the doctors and support staff at the hospital and our team, most importantly to the first Japanese patient to participate in and be dosed with ICEF15!!!

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