Autologous Cell Therapy for Treatment of Fecal Incontinence

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