At a glance
ClinicalIndex Comparison RecordPhase 1Active· 10 target
Drug / intervention
Bioengineered Internal Anal Sphincterbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Treatment Study to Assess Safety and Proof of Concept to Assess Potential Efficacy of the Implanted Internal Anal Sphincter BioSphincterTM Bioengineered From Autologous Cells to Treat Patients With Severe Passive Fecal Incontinence
In Brief
A Phase 1 clinical trial evaluating Bioengineered Internal Anal Sphincter for Fecal Incontinence. Active but no longer recruiting, targeting 10 participants across 1 site.
Detailed Summary
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesUnited States
Collaborators--
Timeline
Phase 1Active
20232024202520262027
Enrollment StartNov 2022
First PostedNov 2022
TodayJul 2026
Primary CompletionJul 2027
First PostedNov 15, 2022
Enrollment StartNov 2, 2022
Primary CompletionJul 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 3.6 years agoPrimary completion in 12 months
Interventions
Bioengineered Internal Anal Sphincterbiological
Autologous Bioengineered Internal Anal Sphincter