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Completed

NCT Number: NCT01600755

Autologous Cell Therapy 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.

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Key information

Conditions

Fecal Incontinence Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iltamiocel

Biological

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

Other names: Autologous Muscle-Derived Cells (AMDC)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Cook MyoSite

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
May 17, 2012
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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