ICES13

Target Indication

Stress urinary incontinence (SUI) is a condition marked by involuntary urine leakage during physical activity, coughing, or sneezing. It is commonly caused by weakened pelvic floor muscles due to aging, childbirth, or surgery.

SUI affects millions globally. In Japan, an estimated 4.61 million women and 820,000 men are impacted¹. In the United States, approximately 15 million adult women experience SUI, while prevalence among men increases with age—from 5% in those aged 19–44 to 21% in men over 65². Across Europe, urinary incontinence affects 10–20% of the population, with stress incontinence accounting for nearly a quarter of cases among women³.

Current treatments include pelvic floor exercises, medications, and surgical procedures. However, many patients experience limited effectiveness or side effects, leaving a significant unmet need for a reliable, long-term solution.

ICES13 offers a regenerative alternative. Developed by Innovacell, ICES13 uses autologous skeletal muscle cells—cultured from the patient’s own biopsy—and injects them into the urethral sphincter to restore muscle function. This approach targets the root cause of SUI and aims to provide sustained relief without implants or invasive surgery.

1. Japanese epidemiological survey, 2002.
2. Urology Care Foundation – Stress Urinary Incontinence
3. European Association of Urology – Prevalence Survey

Developmental Product Features

Mechanism of Action

The cells used in ICEF16 are skeletal muscle-derived smooth muscle cells (skSMC) manufactured from biopsies acquired 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, with a patent currently pending.

ICEF13 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 ICEF13 involves injecting autologous skeletal muscle-derived cells into the urethral 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.