Autologous Cell Therapy for Treatment of Fecal Incontinence

June 30, 2023 updated by: Cook MyoSite

A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to test the safety and feasibility of iltamiocel (Autologous Muscle Derived Cells, AMDC) as a treatment for fecal incontinence in men and women. Iltamiocel therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects or a generalized weakening of the external anal sphincter.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
  • United Kingdom
      • London, United Kingdom
        • Royal London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
  • Wexner (Cleveland Clinic Incontinence Severity (CCIS)) score ≥ 9
  • Etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction
  • Failed conservative treatment

Exclusion Criteria:

  • Gracilis sling repair or insertion of an artificial sphincter
  • Inflammatory Bowel Disease
  • Significant rectocele or rectal prolapse
  • History of radiation treatment to the anal sphincter or adjacent structures
  • Less than 18 years of age
  • Pregnant, breastfeeding, or plans to become pregnant during the course of the study
  • Neuromuscular disorder
  • History of neoplasia within 5 years prior to enrollment, except for basal cell carcinoma, or is receiving or planning to receive anti-cancer medications
  • Known bleeding diathesis or uncorrected coagulopathy
  • Medical condition that would preclude treatment due to contraindications and/or warnings of concomitant medications or listed in the experimental product labeling
  • Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
  • Participating in another investigational drug or device study
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to commit to the follow-up procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intrasphincteric injection of 250 x 10^6 cells.
Biological: Iltamiocel
Single intrasphincteric injection of iltamiocel at a dose of 250 x 10^6 cells
Other Names:
  • Autologous Muscle-Derived Cells (AMDC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment-Related Adverse Events
Time Frame: 12 months
Assessment of frequency and severity of adverse events related to study product and study procedures through 12 months following treatment of FI in adult male and female subjects.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)
Time Frame: 3, 6, and 12 months post-treatment
Median number of fecal incontinence (FI) episodes as assessed by 28-day FI diary.
3, 6, and 12 months post-treatment
Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)
Time Frame: 3, 6, and 12 months post-treatment
Median number of days with fecal incontinence (FI) episodes, as assessed by 28-day FI diary.
3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes
Time Frame: 3, 6, and 12 months post-treatment
Number of participants with categorical ≥50% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes
Time Frame: 3, 6, and 12 months post-treatment
Number of participants with categorical ≥75% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
3, 6, and 12 months post-treatment
Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes
Time Frame: 3, 6, and 12 months post-treatment
Number of participants with 100% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire)
Time Frame: 3, 6, and 12 months post-treatment
Mean change from baseline in patient-reported quality of life, as assessed by the Fecal Incontinence Quality of Life (FIQL) questionnaire. The FIQL is a validated, 29-item tool assessing the quality of life (QOL) of subjects with FI with four scales: Lifestyle (10 items, scored 0 to 4, with higher scores indicating a better QOL), Coping/Behavior (9 items, scored 0 to 4, with higher scores indicating a better QOL), Depression/Self-Perception (7 items, scored 0 to 4, with higher scores indicating a better QOL), and Embarrassment (3 items, scored 0 to 4, with higher scores indicating a better QOL).
3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS))
Time Frame: 3, 6, and 12 months post-treatment
Mean change from baseline in patient-reported fecal incontinence symptom severity, as assessed by the Cleveland Clinic Incontinence Score (CCIS) questionnaire. CCIS is a validated 5-questions tool assessing the frequency and the type of incontinence episodes (solid, liquid, gas), pad use, and lifestyle alteration. Scored from 0 to 20, with lower scores indicating less severe symptoms.
3, 6, and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook MyoSite

Investigators

  • Principal Investigator: Manoj J Raval, MD, St. Paul's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2013

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimated)

May 17, 2012

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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