Cook MyoSite and Veristat have reached a key enrolment milestone in the DigniFI trial, a two-stage, randomised, controlled Phase 3 study testing iltamiocel in women with chronic faecal incontinence linked to obstetric anal sphincter injury.

Veristat, a contract research organisation, supported Cook MyoSite in activating 26 trial sites and enrolling more than 100 participants, with adherence above 95%.

Chronic faecal incontinence is the unintended loss of stool for at least six months. In women, a common cause is anal sphincter injury during childbirth. Cook MyoSite is developing iltamiocel, a personalised cell therapy, as a potential treatment for patients who have few options available.

Ron Jankowski, vice president of regulatory and scientific affairs at Cook MyoSite, said: “Cook MyoSite has been researching and advancing personalised cell therapy treatment for women who have historically been underserved. We look forward to seeing the outcome of the study and the potential impact for women suffering from chronic FI in the future.”

Cindy Henderson, chief strategy officer at Veristat, added: “Cook MyoSite represents the best of clinical development. They are passionate about solving unmet clinical needs for as many patients as possible using the most advanced personalised medical science. We are honoured to partner with such an innovative and committed organisation and look forward to continuing the journey to approval by their side.”