Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.

Official Title
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Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Biological: aSMDC
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years old Patients who are mentally competent and able to understand all study requirements Female patients of childbearing potential willing to use appropriate methods of contraception Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months Urge fecal incontinence episodes that occur more than twice a week Incremental voluntary maximum squeeze pressure on anal manometry is 100mmHg or less in women and 150mmHg or less in men Ultrasound of the anal canal showing the overall extent of external anal sphincter injury and tear of 180 degrees or less Exclusion Criteria: Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound Patients who underwent any anorectal surgery within 6 months before screening visit Patients who underwent a total of two or more external anal sphincter-related surgeries Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures Patients with poorly controlled chronic constipation including obstructed defecation syndrome Patients with indications against a surgery under anesthesia Patients with a malignant disease not in remission for 5 years or more Patients who have undergone radiation therapy of the bowel and pelvis Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy Patients with a diagnosis of chronic inflammatory bowel disease Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons (4 weeks) Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator) Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders Patients with severe myocardial disorders, irregular pulse or a pacemaker Patients with implantations of metal components in the electrical stimulation treatment area Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aSMDC<br>Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence | Biological: aSMDC<br>* Autologous Muscle Derived Cells for injection into the external anal sphincter<br>|
| Placebo Comparator: Placebo<br>Placebo control is the vehicle solution used for the study product | Other: Placebo<br>* Placebo control is the vehicle solution used for the study product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in frequency of incontinence episodes | Urge fecal incontinence | 12 Months |