drugset / Trial / NCT05776277
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.
Timeline
- Start
- 2024-03-21
- Primary completion
- 2026-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iltamiocel | Cell therapy | 3e+08 cells | Other |
Indications
No indication recorded.