The clinical trial application for a Phase III study of autologous skeletal muscle-derived cells (ICEF15) targeting fecal incontinence has been submitted.

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 it submitted a clinical trial application for a Phase III study using autologous myoblast-derived cell therapy product (ICEF15) to the Pharmaceuticals and Medical Devices Agency (PMDA) on September 30, 2022, and that it has been accepted.

This application is intended for participation from Japan in the international multicenter clinical trial already underway in Europe, 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). The trial focuses on urgent fecal incontinence and will enroll a total of 290 patients, who will be allocated in a 1:1 ratio to two groups (treatment drug and placebo) 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.

“I am filled with immense gratitude to everyone inside and outside the company who contributed to the submission of this clinical trial application.

We have taken a significant step forward in delivering a new treatment option, ICEF15, to patients in Japan. We will continue our efforts to address the 30-day investigation by the PMDA, engage with medical staff at the participating clinical trial sites, and provide explanations to the ethics review board, all aimed at our next goal of starting patient enrollment.”

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