Autologous Cell Therapy for Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC; a preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

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

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Biological: Autologous Muscle-Derived Cells (AMDC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination Wexner score ≥ 9 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Muscle-Derived Cells<br>Cell Treatment | Biological: Autologous Muscle-Derived Cells (AMDC)<br>* Cell Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Related Adverse Events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Incontinent Episodes |  | 12 Months | 
| Incontinence Score |  | 12 Months | 
| Sphincter Pressure |  | 12 Months | 
| Fecal Incontinence Quality of Life Scale (FIQL) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell Therapy, Autologous Cell Transplantation, Muscle-derived Cell, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence