The 30-day investigation regarding the clinical trial application submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) 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 the 30-day investigation regarding the clinical trial application submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) has been completed as we begin domestic development of autologous skeletal muscle-derived cells (ICEF15) targeting fecal incontinence.
This clinical trial will participate in the international multicenter trial that has already begun 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.” It will focus on urgent fecal incontinence, enrolling a total of 290 patients, who will be allocated in a 1:1 ratio to two groups (treatment product 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.
About ICEF15
This product aims to treat urgent fecal incontinence by utilizing the patient’s own myoblasts to achieve muscle regeneration through “local administration.