Enrollment of Patients for Phase III Trial of Autologous Skeletal Muscle-Derived Cells (ICEF15) for Fecal Incontinence Has Begun

Innovacell K.K. (Headquarters: Shibuya, Tokyo; CEO: Colin Lee Novick, Jason David Sieger) aims to enhance people’s health and quality of life through cell therapy for the treatment of fecal incontinence and urinary incontinence. We are pleased to announce that the first patient has been enrolled in the Phase III trial using the autologous muscle-derived cell therapy product, (ICEF15) in Europe (Bulgaria) on May 11.

Update: Following Bulgaria, a patient was also enrolled in Spain on May 17 (local time).

This trial is a multi-center, placebo-controlled, randomized, double-blind comparative study targeting fecal incontinence, specifically urgent fecal incontinence, to evaluate the efficacy and safety of ICEF15. Eligible patients will be assigned in a 1:1 ratio to either the treatment or placebo group. The primary endpoint is the change in fecal incontinence frequency compared to baseline at 12 months post-treatment.

“We are thrilled to have reached the ‘First Patient In’ milestone for the Phase III trial, marking an important step toward delivering ICEF15 to patients. We will continue to progress patient enrollment in the participating countries and work diligently to initiate the trial in Japan as well.”

ICEF15 utilizes the patient’s own muscle precursor cells to promote muscle regeneration through local administration, aiming to treat urgent fecal incontinence.

Fecal incontinence is defined as the involuntary loss of feces from the rectum. It poses significant social and hygiene challenges, leading to loss of self-esteem, social isolation, and decreased quality of life. It is estimated that there are over 5 million potential patients with fecal incontinence in Japan.

There is an ongoing expectation for the development of low-invasive, safe, and long-term effective surgical treatments for fecal incontinence.