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ICEF 15 is an autologous cell therapy composed of skeletal muscle-derived cells, developed for the treatment of fecal incontinence, particularly urge incontinence due to external anal sphincter dysfunction. The therapy involves harvesting skeletal muscle cells from the patient, expanding them in vitro, and then injecting them into the damaged or weakened external anal sphincter with the aim of regenerating and restoring its function. This regenerative approach targets causal improvement rather than symptomatic relief. ICEF 15 is being developed by Innovacell Biotechnologie (also referred to as Innovacell GmbH/AG) in collaboration with Norgine. As of June 2025, it has reached Phase III clinical trials across multiple European countries and Japan but has not yet received regulatory approval[1][2][3][4].
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