Pittsburgh, Pa., August 23, 2024 — Cook MyoSite announced that the first participant was treated in the DigniFI Study, a two-stage, randomized, controlled Phase III trial comparing the safety and efficacy of iltamiocel with placebo in the treatment of female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury (OASI). The procedure was performed on August 19 at Segal Trials in Miami, FL, by Principal Investigator Steven E. Chavoustie, MD, FACOG, CCRP.
“Everyone at Segal Trials is thrilled to have treated this first DigniFI Study participant. This study represents a large opportunity to support women who have given birth and are experiencing fecal incontinence,” said Dr. Chavoustie. “There is an unmet need for the large demographic suffering from fecal incontinence, which includes 1 in 10 women who have given birth1.”
Chronic fecal incontinence (FI) is characterized by the unintended loss of liquid or solid stool occurring for at least 6 months. A common cause of chronic FI in women is anal sphincter injury, such as an episiotomy or perineal tear, which can occur during childbirth. New treatment options are needed for these women who can experience profound negative impacts to their quality of life.
“On behalf of Cook MyoSite, we are very excited to announce the first participant treated as part of the DigniFI Study,” said Ron Jankowski, Vice President, Regulatory and Scientific Affairs at Cook MyoSite. “We continue our dedicated efforts toward researching and advancing personalized cell therapy treatments for underserved and serious quality of life conditions which, unfortunately, are all-too common in the realm of women’s health. Today marks an important milestone in advancing potential treatment options for women experiencing chronic fecal incontinence symptoms, an understated and serious condition with unmet medical need.”
The DigniFI Study seeks to enroll up to 200 female participants with chronic fecal incontinence and a history of OASI. The study will evaluate the safety and efficacy of the investigational regenerative medicine, iltamiocel, which is prepared from a small sample of the participants own muscle tissue.
For more information about the DigniFI Study, visit www.DigniFIstudy.com.
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