Innovacell Inc. (https://innovacell.com/) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for the international joint Phase III clinical trial of ICEF15 (the Fidelia study), currently being conducted by the company group in Japan and Europe, has completed its 30-day review period, and that the trial can commence in the United States. This allows for the formal enrollment of U.S. sites and patients in the Fidelia study. ICEF15, the most advanced candidate in the company group's pipeline, aims to provide a fundamental treatment for urge fecal incontinence by locally administering the patient's own skeletal muscle-derived cells into the external anal sphincter to promote muscle repair and regeneration. Fecal incontinence is defined as the involuntary leakage of stool from the anus, and it is said that approximately 5 million people in Japan suffer from this condition (Source: Website of the Japan Society of Coloproctology). According to a paper published in a specialized academic journal (Toshiki Aimura et al., "Investigation Report on the Actual Status of Fecal Incontinence Management in Japan - Current Status of Diagnosis and Treatment -" Journal of Japan Society of Coloproctology 65: 101-108, 2012), more than half (approximately 51%) of patients with fecal incontinence have urge symptoms. For patients with urge fecal incontinence who do not achieve sufficient improvement with conservative therapy (such as medication), surgical therapy (such as anal sphincteroplasty or sacral nerve stimulation) is applied. However, existing surgical therapies are considered to be highly invasive (burden on the patient's body) and may not always be sufficiently effective. ICEF15 has the potential to be a treatment option with lower invasiveness and potentially higher efficacy for patients who do not achieve adequate improvement with conservative therapy. The company group is currentl