Cell therapy for treating fecal incontinence (passive incontinence).

ICEF16

Around half of the patients with fecal incontinence suffer from passive incontinence. In contrast to urge incontinence, those affected by passive incontinence do not feel an urge to defecate, which can lead to unconscious stool loss. In many cases passive incontinence is the result of a deficiency with the patient’s internal anal sphincter.

Treatment options today include behavioural 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.

Cell therapy with autologous muscle cells has the potential to be a promising treatment method for passive incontinence. In contrast to the sphincter muscles treated with ICES13 and ICEF15, which consist of skeletal muscles, ICEF16 treats the damaged smooth sphincter muscle responsible for passive incontinence. Smooth muscles are difficult to access for a biopsy. Therefore, suitable precursor cells are isolated from skeletal muscle and differentiated into smooth muscle cells. A patent has been applied for this differentiation technology, which has been proven in both in vitro and in vivo studies.

Development Status ICEF16

EU

Preclinical

Clinical

Approval

Status

Preclinical safety and efficacy tests
Japan

Preclinical

Clinical

Approval

Status

Preclinical safety and efficacy tests
USA

Preclinical

Clinical

Approval

Status

Preclinical safety and efficacy tests