Cell therapy for treating fecal incontinence (urge incontinence)

ICEF15

Fecal incontinence is a condition that affects around 10% of adults (older than 20 years). One cause of fecal incontinence is damage to or weakening of the responsible sphincter. Such damage can occur during childbirth, which is why women are more likely to suffer from fecal incontinence than men.

Medically, a distinction is made between urge incontinence and passive incontinence. In the case of urge incontinence, there is often an impairment of the external sphincter and thus the striated skeletal muscles. Patients who are affected by this form of incontinence experience a sudden urge to defecate that cannot be controlled, and this involuntary defecation occurs before a toilet can be reached. Treatment options today include behavioral approaches, such as changing food intake. If these do not achieve the desired result, therapies such as biofeedback are used, followed by pharmaceuticals such as loperamide, an antidiarrheal. Most of the time, however, these treatments are not sufficiently effective, so patients are subjected to invasive interventions such as implanting an electrical stimulation device or an artificial sphincter. However, these treatments will oftentimes result in various comorbidities. If all therapy options have been exhausted and if necessary a colostomy is performed. This is a surgical procedure that creates an artificial anus through the abdominal wall. Considering these forms of therapy are often unsatisfactory, the need for effective and safe treatment is very high.

Innovacell has been developing ICEF15 for the treatment of urge incontinence since 2006. In contrast to therapies already in use, treatment with ICEF15 aims at a causal and thus regenerative improvement of the external rectal sphincter. The function of the damaged sphincter muscle is to be restored by injecting ICEF15 (autologous skeletal muscle cells that have been reproduced in vitro).

Several Phase I/II clinical studies with ICEF15 have been successfully completed; the results are very promising. In Japan, approval will be sought along the “conditional approval pathway” in 2023 after another clinical study. A European phase III study is also in preparation. Approval of ICEF15 in the EU is planned for 2024, followed by approval in the USA in 2026. To date, study results from 19 clinics in 8 European countries are available.

Development Status ICEF15

EU

Preclinical

Clinical

Approval

Status

Recruiting Phase III
Japan

Preclinical

Clinical

Approval

Status

Study preparation (Phase III)
USA

Preclinical

Clinical

Approval

Status

Scientific Advice conducted