Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Phase 3

Recruiting

• Conditions: Fecal Incontinence
• Interventions: Biological: aSMDC; Other: Placebo

• Registration Number: NCT04976153
• Lead Sponsor: Innovacell AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-26
• Study Start: 2022-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-03-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

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
• Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men
• 9. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees

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 (e.g Crohn's disease, Colitis Ulcerosa)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aSMDC	aSMDC	Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence
Placebo	Placebo	Placebo control is the vehicle solution used for the study product

Primary Outcome Measures

Name	Time	Method
Changes in frequency of incontinence episodes	12 Months	Urge fecal incontinence

Trial Locations

Locations (31)

Hosp. General Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Luis Garcia Florez; 🇪🇸 Oviedo, Spain

Danderyd Sjukhus; 🇸🇪 Danderyd, Sweden

Skånes Universitetssjukhus, Malmo; 🇸🇪 Malmö, Sweden

Östersund sjukhus, Kirurgiska kliniken; 🇸🇪 Östersund, Sweden

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Hospital de Mataro; 🇪🇸 Mataró, Spain

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Medical University Graz; 🇦🇹 Graz, Austria

Medical Center Unimed EOOD; 🇧🇬 Sevlievo, Bulgaria

Fakultni nem. u sv. Anny v Brne; 🇨🇿 Brno, Czechia

The Institute for the Care of Mother and Child; 🇨🇿 Prague, Czechia

Deaconess Hospital Group Croix Saint - Simon; 🇫🇷 Paris, France

Hospital Bichat - Claude Bernard; 🇫🇷 Paris, France

CHU Rennes - Hospital Pontchaillou; 🇫🇷 Rennes, France

CHU de Rouen; 🇫🇷 Rouen, France

Heidelberg University, Medical Faculty Mannheim, Department of surgery; 🇩🇪 Mannheim, Germany

IRCCS Ospedale San Raffaele; 🇮🇹 San Donato Milanese, Italy

Hokkaido Railway Company JR Sapporo Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Tsujinaka Hospital, Coloproctological Surgery; 🇯🇵 Chiba, Japan

Teikyo University Chiba Medical Center; 🇯🇵 Chiba, Japan

Kurume Hospital; 🇯🇵 Fukuoka, Japan

Hiroshima Memorial Hospital; 🇯🇵 Hiroshima, Japan

Meiwa Hospital; 🇯🇵 Hyogo, Japan

Matsushima Hospital; 🇯🇵 Kanagawa, Japan

Coloproctology Center Takano Hospital; 🇯🇵 Kumamoto, Japan

Japan Post Kyoto Teishin Hospital; 🇯🇵 Kyoto, Japan

Jichi Medical University Hospital; 🇯🇵 Tochigi, Japan

Juntendo University Hospital; 🇯🇵 Tokyo, Japan

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie; 🇵🇱 Kraków, Poland

Corporacio Sanitaria Parc Tauli; 🇪🇸 Barcelona, Spain