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Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Study acronym: CELLEBRATE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites revised (21)v50
  2. Re-verified, no change to tracked fieldsv49
  3. Primary completion date: Feb 2025 to Sep 2026
    • Study sites: 20 to 21
    • Study completion date: Feb 2026 to Sep 2027
    v48
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 35 to 20
    • Primary completion date: Jan 2025 to Feb 2025
    v47
  5. Re-verified, no change to tracked fieldsv46
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 1 of 35 sitesv45
  2. Site details revised at 1 of 35 sitesv44
  3. Study sites: 34 to 35v43
  4. Enrollment target: 260 to 96
    • Site details revised at 3 of 34 sites
    • Study title shortened, about 10 words
    v42
  5. Study sites: 35 to 34v41
  6. Study sites: 34 to 35v40
  7. Study sites: 33 to 34v39
  8. Re-verified, no change to tracked fieldsv38
  9. Study sites: 32 to 33v37
  10. Site details revised at 4 of 32 sitesv36
  11. Study sites: 26 to 32v35
  12. Site details revised at 1 of 26 sitesv34
  13. Site details revised at 1 of 26 sitesv33
  14. Study sites: 25 to 26v32
  15. Primary completion date: Sep 2022 to Jan 2025v31 Show 7 more changesShow less
    • Enrollment target: 320 to 260
    • Study completion date: Sep 2023 to Feb 2026
    • Interventions: AMDC-USR (Biological), Placebo (Other) to AMDC-USR (iltamiocel) (Biological), Placebo (Other)
    • Eligibility criteria expanded, about 31 words
    • Site details revised at 1 of 25 sites
    • Study title expanded, about 10 words
    • Study description expanded, about 3 words
  16. Study sites: 24 to 25v30
  17. Site details revised at 1 of 24 sitesv29
  18. Site details revised at 1 of 24 sitesv28
  19. Site details revised at 1 of 24 sitesv27
  20. Site contacts updated at 1 of 24 sitesv26
  21. Re-verified, no change to tracked fieldsv25
  22. Site details revised at 1 of 24 sitesv24
  23. Site details revised at 1 of 24 sitesv23
  24. 2 versions Re-verified since Apr 14, 2021, no change to tracked fieldsv21-v22
  25. Study sites: 22 to 24v20
  26. Site details revised at 4 of 22 sitesv19
  27. Study sites revised (22)v18
  28. Study sites: 21 to 22v17
  29. Study sites: 19 to 21v16
  30. Study sites: 18 to 19v15
  31. Study sites: 16 to 18v14
  32. Study sites: 12 to 16v13
  33. Re-verified, no change to tracked fieldsv12
  34. Study sites: 6 to 12v11
  35. Start date: Mar 20, 2019 to Apr 23, 2019v10
  36. Start date: Feb 3, 2019 to Mar 20, 2019
    • Study sites: 1 to 6
    v9
  37. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2018 to Feb 3, 2019
    • Study sites: 0 to 1
    v8
  38. Re-verified, no change to tracked fieldsv7
  39. Start date: Jul 2018 to Sep 2018
    • Primary completion date: Jul 2022 to Sep 2022
    • Study completion date: Aug 2023 to Sep 2023
    v6
  40. Primary completion date: Jun 2022 to Jul 2022
    • Study completion date: Jul 2023 to Aug 2023
    • Start date: Jun 2018 to Jul 2018
    v5
  41. Re-verified, no change to tracked fieldsv4
  42. Eligibility criteria expanded, about 3 words
    • Collaborators shortened, about 2 words
    v3
  43. Enrollment target: 156 to 320v2 Show 5 more changesShow less
    • Primary completion date: Aug 2019 to Jun 2022
    • Start date: Jun 2017 to Jun 2018
    • Study completion date: Aug 2020 to Jul 2023
    • Eligibility criteria expanded, about 16 words
    • Study title expanded, about 4 words
  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 Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
Trial Details
NCT Number NCT03104517
Lead Sponsor Cook MyoSite
Conditions
(from sponsor)		 Stress Urinary Incontinence
Related terms Lower Urinary Tract Symptoms, Nocturnal Enuresis, Urinary Incontinence, Urinary Incontinence, Stress, Urologic Diseases
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov