6 completed, 4 active not recruiting, 1 enrolling by invitation, 1 not yet recruiting. 6 Phase 2, 5 Phase 1, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Active not recruiting 1, Terminated 1 |
| Phase 1 | 5 | Active not recruiting 2, Completed 2, Terminated 1 |
| Phase 3 | 5 | Active not recruiting 2, Completed 2, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| REVIVE Prospective Registry Cohort Study Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. - Oropharyngeal Dysphagia | Not yet recruiting | University of California, Davis | 31 | 2026-08-30 | 2026-06-18 | |
| Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1) AMDC-USR, Placebo - Stress Urinary Incontinence | Phase 3 | Withdrawn | Cook MyoSite | 2025-06-01 | 2024-08-27 | |
| Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence iltamiocel - Stress Urinary Incontinence | Enrolling by invitation | Cook MyoSite | 96 | 2025-04-11 | 2026-07-22 | |
| Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury Iltamiocel, Placebo - Fecal Incontinence | Phase 3 | Active not recruiting | Cook MyoSite | 200 | 2024-03-21 | 2026-10-20 |
| Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR), Placebo - Oropharyngeal Dysphagia | Phase 1 / Phase 2 | Active not recruiting | University of California, Davis | 66 | 2022-05-26 | 2025-12-12 |
| Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence AMDC-USR (iltamiocel), Placebo - Stress Urinary Incontinence | Phase 3 | Active not recruiting | Cook MyoSite | 96 | 2019-04-23 | 2026-10-21 |
| Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) - Oropharyngeal Dysphagia | Phase 1 | Active not recruiting | Peter Belafsky, MD | 18 | 2017-05-24 | 2026-04-20 |
| Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery autologous muscle-derived cells (AMDC) - Urinary Incontinence, Stress | Phase 1 / Phase 2 | Completed | Cook MyoSite | 25 | 2015-02-19 | 2021-11-01 |
| Autologous Muscle Derived Cells for Female Urinary Sphincter Repair Placebo, Iltamiocel - Stress Urinary Incontinence | Phase 3 | Completed | Cook MyoSite | 311 | 2013-11-21 | 2023-01-05 |
| Autologous Cell Therapy for Treatment of Fecal Incontinence Iltamiocel - Fecal Incontinence | Phase 1 / Phase 2 | Completed | Cook MyoSite | 53 | 2013-03-28 | 2024-02-16 |
| Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study AMDC-USR, Placebo - Urinary Incontinence, Stress | Phase 3 | Completed | Cook MyoSite | 150 | 2011-11-04 | 2018-05-17 |
| Autologous Cell Therapy for Ischemic Heart Failure AMDC - Ischemic Heart Disease | Phase 1 / Phase 2 | Terminated | Cook MyoSite | 9 | 2011-02-05 | 2021-07-01 |
| Autologous Cell Therapy for Female Stress Urinary Incontinence Autologous Muscle Derived Cells - Stress Urinary Incontinence | Phase 2 | Completed | Cook MyoSite | 16 | 2010-06-02 | 2021-07-01 |
| An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence autologous muscle cell injection - Stress Urinary Incontinence, Cell Therapy | Phase 2 | Completed | Cook MyoSite | 66 | 2008-10-09 | 2023-09-08 |
| Expanded Access Program for Autologous Muscle Derived Cells (AMDCs) Autologous Muscle Derived Cells (AMDCs) | Temporarily not available | Cook MyoSite | 2026-02-13 |
Urinary Incontinence, Stress (8) · Urinary Incontinence (4) · Deglutition Disorders (3) · Lower Urinary Tract Symptoms (3) · Urologic Diseases (3) · Encopresis (2) · Fecal Incontinence (2) · Gastrointestinal Diseases (2) · Intestinal Diseases (2) · Nocturnal Enuresis (2) · Rectal Diseases (2) · Heart Diseases (1) · Heart Failure (1) · Myocardial Infarction (1) · Myocardial Ischemia (1)
United States (10) · Canada (5) · United Kingdom (3) · Germany (2) · Belgium (1)
Melissa Kaufman, M.D., Ph.D. (3) · Kenneth Peters, MD (2) · Maggie Kuhn, MD (2) · Peter Belafsky, MD (2) · Ron Jankowski, PhD (2) · Hung Q. Ly, MD (1) · Johnathon D Anderson, PhD (1) · Lesley K. Carr, MD (1) · Lesley K. Carr, MD, FRCSC (1) · Manoj J Raval, MD (1) · Nogah Nativ, PhD (1) · Peter Belafsky, MD, PhD (1)