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

Study acronym: DigniFI
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Mar 11, 2026, no change to tracked fieldsv25-v27
  2. Study sites: 26 to 25
    • Primary completion date: Sep 2026 to Dec 2026
    • Study completion date: Sep 2027 to Dec 2027
    v24
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 26 of 26 sites
    v23
  4. Re-verified, no change to tracked fieldsv22
  5. Study sites: 25 to 26v21
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 1 of 25 sitesv20
  2. Study sites: 24 to 25v19
  3. Site contacts updated at 22 of 24 sitesv18
  4. Study sites: 23 to 24v17
  5. Study sites: 19 to 23v16
  6. Study sites: 13 to 19v15
  7. Eligibility criteria shortened, about 11 wordsv14
  8. Site details revised at 2 of 13 sitesv13
  9. Study sites revised (13)v12
  10. Study sites: 12 to 13v11
  11. Study sites: 10 to 12v10
  12. Start date changed from estimate of Mar 2024 to Mar 21, 2024
    • Site details revised at 2 of 10 sites
    v9
  13. Study sites: 8 to 10
    • Start date: Feb 2024 to Mar 2024
    v8
  14. Start date: Jan 2024 to Feb 2024
    • Site details revised at 1 of 8 sites
    v7
  15. Study sites: 1 to 8
    • Start date: Dec 2023 to Jan 2024
    v6
  16. Re-verified, no change to tracked fieldsv5
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2023 to Dec 2023
    • Study sites: 0 to 1
    v4
  18. Re-verified, no change to tracked fieldsv3
  19. Eligibility criteria expanded, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05776277
Lead Sponsor Cook MyoSite
Conditions
(from sponsor)		 Fecal Incontinence
Related terms Encopresis, Fecal Incontinence, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov