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Cook MyoSite

HQ: Pittsburgh, PA source · cookmyosite.com ↗

Clinical Phase 3

Keywords: cell therapy Stress Urinary Incontinence Fecal Incontinence Urinary Incontinence Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Ischemic Heart Disease Iltamiocel Autologous Muscle Derived Cells AMDC-USR AMDC-USR (iltamiocel)

Location: Pittsburgh, PA · source · Oct 15, 2026

Profile checked Oct 10, 2026

12Trials (company is sponsor)

Timeline

  1. Trial start Phase 3: Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1) source ↗
  2. Trial start —: Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence source ↗
  3. Trial start Phase 3: Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury source ↗
  4. Trial start Phase 3: Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence source ↗
  5. Trial start Phase 1/Phase 2: Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery source ↗
  6. Trial start Phase 3: Autologous Muscle Derived Cells for Female Urinary Sphincter Repair source ↗
  7. Trial start Phase 1/Phase 2: Autologous Cell Therapy for Treatment of Fecal Incontinence source ↗
  8. Trial start Phase 3: Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study source ↗
  9. Trial start Phase 1/Phase 2: Autologous Cell Therapy for Ischemic Heart Failure source ↗
  10. Trial start Phase 2: Autologous Cell Therapy for Female Stress Urinary Incontinence source ↗
  11. Trial start Phase 2: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 12

RecordTitlePhaseStatusStartPrimary completion
NCT06743620Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress IncontinenceNot listedEnrolling by invitationApr 11, 20252032-04 (estimated)
NCT05776277Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric InjuryPhase 3Active, not recruitingMar 21, 20242026-12 (estimated)
NCT03104517Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress IncontinencePhase 3Active, not recruitingApr 23, 20192026-09 (estimated)
NCT04661293Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)Not listedTemporarily not availableNot listedNot listed
NCT03997318Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)Phase 3Withdrawn2025-062026-06 (estimated)
NCT01600755Autologous Cell Therapy for Treatment of Fecal IncontinencePhase 1/Phase 2CompletedMar 28, 2013Oct 27, 2021 (actual)
NCT00847535An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary IncontinencePhase 2CompletedOct 9, 2008Nov 2, 2011 (actual)
NCT01893138Autologous Muscle Derived Cells for Female Urinary Sphincter RepairPhase 3CompletedNov 21, 2013Nov 1, 2019 (actual)
NCT02291432Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate SurgeryPhase 1/Phase 2CompletedFeb 19, 2015Jun 28, 2019 (actual)
NCT01008943Autologous Cell Therapy for Female Stress Urinary IncontinencePhase 2CompletedJun 2, 2010Sep 21, 2012 (actual)
NCT01353690Autologous Cell Therapy for Ischemic Heart FailurePhase 1/Phase 2TerminatedFeb 5, 2011Dec 12, 2012 (actual)
NCT01382602Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical StudyPhase 3CompletedNov 4, 2011Feb 3, 2016 (actual)
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