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Autologous Cell Therapy for Treatment of Fecal Incontinence

NCT01600755 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-02-16

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

BIOLOGICAL

Iltamiocel

Single intrasphincteric injection of iltamiocel at a dose of 250 x 10\^6 cells

Sponsors & Collaborators

  • Cook MyoSite

    lead INDUSTRY

Principal Investigators

  • Manoj J Raval, MD · St. Paul's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2021-10-27
Completion
2021-10-27

Countries

  • Canada
  • 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 NCT01600755 on ClinicalTrials.gov