First patient enrolled in Japan for the Phase III trial of autologous skeletal muscle-derived cells (ICEF15) targeting fecal incontinence.

Innovacell K.K. (Headquarters: Shinagawa, 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 the enrollment of the first patient in Japan for a Phase III trial using autologous skeletal muscle-derived cells (ICEF15) targeting fecal incontinence.

This patient enrollment is part of an international multicenter clinical trial titled “Skeletal Muscle-Derived Cell Transplantation Therapy for Patients with Fecal Incontinence: A Phase III Randomized, Placebo-Controlled, Double-Blind Study Comparing Two Groups” (hereafter referred to as this trial), focusing on urgent fecal incontinence, and marks the first case in Japan.

The trial will allocate a total of 290 patients into two groups (treatment drug and placebo) in a 1:1 ratio to evaluate the efficacy and safety of ICEF15. The primary endpoint is the change in the frequency of fecal incontinence from baseline after 12 months of treatment.

“We are very pleased to report the enrollment of the first patient in the Phase III trial in Japan and would like to take this opportunity to thank everyone inside and outside the company for their efforts. In Europe, treatments are being conducted in Spain, Bulgaria, Germany, and other countries, and we will continue to sequentially advance patient enrollment and treatment across all 11 participating countries in this trial.”

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