Innovacell K.K. (Headquarters: Shibuya, Tokyo; Representatives: Colin Lee Novick, Jason David Sieger), which aims to improve people’s health and quality of life (QOL) through cell therapy for the treatment of fecal incontinence and urinary incontinence, is pleased to announce that a paper on the results of the Phase IIb trial using autologous myoblast-derived cell therapy product (ICEF15) targeting fecal incontinence has been published in the American Journal of Clinical Gastroenterology and Hepatology.
The Phase IIb clinical trial of ICEF15 confirmed the high safety and tolerability of our treatment. Additionally, a statistically significant reduction in fecal incontinence frequency was detected in the high-dose group compared to the control group six months after transplantation, achieving the primary endpoint. Furthermore, an exploratory post-hoc analysis focusing on fecal incontinence patients with a history of less than ten years and high incontinence episode frequency (IEF) confirmed further differences between the two groups.
Clinical Gastroenterology and Hepatology is the official clinical practice journal of the American Gastroenterological Association (AGA) (https://gastro.org) and can be accessed at https://www.journals.elsevier.com/clinical-gastroenterology-and-hepatology.
The paper can be accessed here: （https://www.cghjournal.org/article/S1542-3565(22)00729-7/fulltext#relatedArticles , DOI:https://doi.org/10.1016/j.cgh.2022.07.039 , PMID:35961517）
Comment from Colin Novick, CEO
“I am very pleased that we were able to publish the results of the Phase IIb trial of ICEF15 in the journal Clinical Gastroenterology and Hepatology, which is associated with the AGA. I would like to express my heartfelt gratitude to everyone who contributed to achieving these results. I am excited to demonstrate that ICEF15 has the potential to be a wonderful treatment option for patients suffering from fecal incontinence.
Currently, patient enrollment for the Phase III trial is progressing in Europe. We are also working diligently to initiate the trial in Japan as soon as possible and will continue to strive to provide updates on further developments.”
About ICEF15
This product aims to treat urgent fecal incontinence by utilizing the patient’s own myoblasts to achieve muscle regeneration through “local administration.”