At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
ALLO-ASC injection +1 morebiological
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.
Treatment of Fecal Incontinence Using Allogenic-Adipose-derived Mesenchymal Stem Cells: A Prospective, Dose Escalation, Randomized, Placebo-controlled, Parallel-group, Single-blind, Single-center Pilot Study
In Brief
A Phase 1 clinical trial evaluating ALLO-ASC injection and Placebo for Fecal Incontinence. Completed, enrolled 21 participants across 1 site.
Detailed Summary
* Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter. * Method 1. Safety test of allogenic ASCs injection 2. Efficacy test of allogenic ASCs injection
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedMar 2015
Primary CompletionJun 2017
TodayJul 2026
First PostedMar 10, 2015
Enrollment StartDec 1, 2014
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.3 years ago
Interventions
ALLO-ASC injectionbiological
Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence
Placebodrug
0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence