NCT01600755CompletedPhase 1
A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence
Cook MyoSite3 sites in 2 countries53 target enrollmentStarted: March 28, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 3
- Primary Endpoint
- Number of Treatment-Related Adverse Events
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)(3, 6, and 12 months post-treatment)
- Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)(3, 6, and 12 months post-treatment)
- Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes(3, 6, and 12 months post-treatment)
- Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes(3, 6, and 12 months post-treatment)
- Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes(3, 6, and 12 months post-treatment)
- Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire)(3, 6, and 12 months post-treatment)
- Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS))(3, 6, and 12 months post-treatment)
Investigators
Study Sites (3)
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