Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT05776277

Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury (DigniFI)

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 (DigniFI)

Sponsor: Cook MyoSite

Conditions Fecal Incontinence

Interventions Iltamiocel Placebo

Updated 21 times since 2023 Last updated: Mar 11, 2026 Started: Mar 21, 2024 Primary completion: Dec 31, 2026 Completion: Dec 31, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05776277, this PHASE3 trial focuses on Fecal Incontinence and remains ongoing. Sponsored by Cook MyoSite, it has been updated 21 times since 2024, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

21 versions recorded

Mar 2026 — Present [monthly]

Active Not Recruiting PHASE3
Jan 2026 — Mar 2026 [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
May 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Apr 2025 — May 2025 [monthly]

Recruiting PHASE3

▶ Show 16 earlier versions

Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE3
Feb 2025 — Mar 2025 [monthly]

Recruiting PHASE3
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE3
Dec 2024 — Jan 2025 [monthly]

Recruiting PHASE3
Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Recruiting PHASE3
Mar 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Sep 2023 — Jan 2024 [monthly]

Not Yet Recruiting PHASE3
May 2023 — Sep 2023 [monthly]

Not Yet Recruiting PHASE3
Apr 2023 — May 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cook MyoSite

Data source: Cook MyoSite

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Boston, United States , Chicago, United States , Cleveland, United States , Fayetteville, United States , Gainesville, United States , Grand Rapids, United States , Hawthorne, United States , Indianapolis, United States , La Jolla, United States , Miami, United States and 14 more locations