ICEF15

Target Indication

ICEF15 targets urge fecal incontinence, a subtype of fecal incontinence characterized by the inability to retain stool after sensing the urge to defecate. This condition is often caused by damage to the external anal sphincter, leading to involuntary leakage despite conscious effort to prevent it.

Fecal incontinence affects millions worldwide. In Japan, approximately 5 million people are estimated to suffer from the condition. In the United States and Europe, prevalence estimates range from 7% to 15% of the general population, with higher rates among older adults and women^1,2. Studies show that over half of fecal incontinence cases involve urgency symptoms, making urge incontinence a significant clinical concern².

Initial treatment typically involves conservative approaches such as dietary adjustments, antidiarrheal medications, and biofeedback therapy. When these fail, surgical options like anal sphincter reconstruction or sacral nerve stimulation may be considered. However, these procedures are highly invasive and often not preferred by patients seeking less disruptive solutions³.

ICEF15 offers a minimally invasive alternative. Developed by Innovacell, this autologous cell therapy involves culturing skeletal muscle cells from the patient and injecting them into the external anal sphincter to restore muscular function. The approach aims to strengthen the sphincter, improve continence, and reduce the need for surgical intervention.

Currently in Phase III multi-regional clinical trials, ICEF15 is being developed for approval across Japan, Europe, and the United States. Its personalized, regenerative mechanism positions it as a promising solution for patients who do not respond to conventional therapies.

1. International Continence Society – Epidemiology of Fecal Incontinence
2. Frontiers in Surgery – Faecal Incontinence: A Comprehensive Review
3. Mayo Clinic – Fecal Incontinence Treatment Overview

Developmental Product Features

Mechanism of Action

The cells used in ICEF15 are autologous skeletal muscle-derived cells (aSMDC) acquired from the patient themselves. Skeletal muscle-derived cells correspond to ‘myoblasts,’ which are cells that form muscle fibers. These cells promote the regeneration of skeletal muscle by fusing with damaged myotubes – one of the smallest components of muscle fibers. Once incorporated into the myotubes, these cells are believed to contribute to the long-term maintenance of the function of the external anal sphincter.

ICEF15 is classified as a regenerative medicine product under Japanese law, as an ATMP (Advanced Therapy Medicinal Product) in Europe, and as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-based Products) in the United States.

Administration Method

Treatment with ICEF15 involves injecting autologous skeletal muscle-derived cells into the external anal sphincter under ultrasound guidance.

Prior to and following administration, pelvic floor electrical stimulation is performed at home using a handheld device twice a day for a total of four weeks to promote the engraftment of the injected cells.

Ongoing Clinical Trials

Target Indication

Fecal incontinence (IC-01-02-5-009)

Trial Locations

Hokkaido, Tochigi, Chiba, Tokyo, Kanagawa, Kyoto, Hyogo, Fukuoka, Kumamoto

More Information

jRCT (https://jrct.niph.go.jp/)

ClinicalTrial.gov (https://clinicaltrials.gov/)

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