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

09-025

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.

2013-03-28

2021-10-27

2021-10-27

Completed

Early phase I

53

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 53, 'type': 'ACTUAL'}}

2024-02-16