Autologous Cell Therapy for Treatment of Fecal Incontinence
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
Wexner score ≥ 9
Failed conservative treatment
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
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