ICEF16

Target Indication

ICEF16 targets passive fecal incontinence, a condition characterized by involuntary stool leakage without the sensation of urgency. This form of incontinence is typically caused by dysfunction of the internal anal sphincter, which plays a key role in maintaining continence at rest.

Passive fecal incontinence is highly prevalent. Studies estimate that over 80% of fecal incontinence cases involve passive symptoms¹. Globally, fecal incontinence affects 7–15% of the general population, with higher rates among older adults and women². In the United States alone, prevalence estimates range from 14% to 36%, depending on age and comorbidities³.

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 often highly invasive and may not deliver the desired outcomes, leaving a significant unmet need for effective, minimally invasive alternatives.

ICEF16 offers a novel solution. Developed by Innovacell, this autologous cell therapy involves culturing skeletal muscle-derived smooth muscle cells (skSMC) from the patient’s own biopsy and injecting them into the internal anal sphincter to restore muscular function and improve continence—without the need for implants

ICEF16 is classified as a regenerative medicine product under Japanese law, an ATMP (Advanced Therapy Medicinal Product) in Europe, and an HCT/P (Human Cells, Tissues, and Cellular and Tissue-based Product) in the United States. Its personalized, minimally invasive approach positions it as a promising therapy for patients who do not respond to conventional treatments.

1. Frontiers in Surgery – Faecal Incontinence: A Comprehensive Review
2. Mass General – Fecal Incontinence in Older Adults
3. ASCRS Clinical Practice Guidelines

Developmental Product Features

Mechanism of Action

ICEF16 is classified as a regenerative medicine product in Japan, an ATMP (Advanced Therapy Medicinal Product) in Europe, and an HCT/P (Human Cells, Tissues, and Cellular and Tissue-based Product) in the United States.
The cells used in ICEF16 are skeletal muscle-derived smooth muscle cells (skSMC) manufactured from biopsies harvested from the patient themselves. ICEF16 aims to restore the function of damaged smooth muscle; however, the large-scale culture of skeletal muscle-derived cells (SMDC) is challenging, so these cells are differentiated into smooth muscle cells (skSMC). This differentiation technique has been validated through both in vitro and in vivo studies, and a patent is currently pending.

Administration Method

For ICEF16, smooth muscle cells are injected into the internal anal sphincter. Similar to ICEF15, electrical stimulation using a device will be performed before and after administration to promote the engraftment of the injected cells.