A Two-Stage, Randomized, Controlled 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

This research is designed to test iltamiocel (a single injection of 300 x 10^6 cells) compared to a placebo in the in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel and the other half will receive placebo. The primary purpose of this study is to evaluate the efficacy and safety of iltamiocel by measuring the reduction of fecal incontinence episode frequency.

Sponsor

Cook MyoSite, Inc. 

Status of enrollment

Accepting new patients

Ages Eligible for Study

18-65 years

Genders Eligible for Study

Female

Disease indication

Female Fecal Incontinence 

Principal Investigator

Mark Zhao MD

Contact

Isabella Sanchez 

[email protected]

 

 

Additional study eligibility details can be found at UCSF Clinical Trials.