At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
Iltamiocelbiological
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.
A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence
In Brief
A Phase 2 clinical trial evaluating Iltamiocel for Fecal Incontinence. Completed, enrolled 53 participants across 2 sites in 2 countries.
Detailed Summary
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesCanada, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartMar 2013
Primary CompletionOct 2021
TodayJul 2026
First PostedMay 17, 2012
Enrollment StartMar 28, 2013
Primary CompletionOct 27, 2021
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 14.1 years ago
Interventions
Iltamiocelbiological
Single intrasphincteric injection of iltamiocel at a dose of 250 x 10\^6 cells