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Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

NCT04976153 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-03-12

No results posted yet for this study

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

  • Fecal Incontinence

Interventions

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

Sponsors & Collaborators

  • Innovacell GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2027-03-31
Completion
2027-07-31

Countries

  • Austria
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976153 on ClinicalTrials.gov