Trials / Recruiting
RecruitingNCT04976153
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- Sponsor
- Innovacell GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aSMDC | Autologous Muscle Derived Cells for injection into the external anal sphincter |
| OTHER | Placebo | Placebo control is the vehicle solution used for the study product |
Timeline
- Start date
- 2022-05-11
- Primary completion
- 2027-03-31
- Completion
- 2027-07-31
- First posted
- 2021-07-26
- Last updated
- 2025-03-12
Locations
31 sites across 11 countries: Austria, Bulgaria, Czechia, France, Germany, Italy, Japan, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT04976153. Inclusion in this directory is not an endorsement.