Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
NCT ID: NCT04976153
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
290 participants
INTERVENTIONAL
2022-05-11
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
NCT01949922
Muscle Progenitor Cell Therapy for Urinary Incontinence
NCT01953315
Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
NCT04729582
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
NCT00847535
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
NCT00200057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aSMDC
Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence
aSMDC
Autologous Muscle Derived Cells for injection into the external anal sphincter
Placebo
Placebo control is the vehicle solution used for the study product
Placebo
Placebo control is the vehicle solution used for the study product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aSMDC
Autologous Muscle Derived Cells for injection into the external anal sphincter
Placebo
Placebo control is the vehicle solution used for the study product
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovacell GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Landeskrankenhaus Feldkirch
Feldkirch, , Austria
Medical University Graz
Graz, , Austria
Medical Center Unimed EOOD
Sevlievo, , Bulgaria
Fakultni nem. u sv. Anny v Brne
Brno, Brno, Czechia
The Institute for the Care of Mother and Child
Prague, , Czechia
Deaconess Hospital Group Croix Saint - Simon
Paris, France, France
Hospital Bichat - Claude Bernard
Paris, France, 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
Hyōgo, , 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
Krakow, , Poland
Corporacio Sanitaria Parc Tauli
Barcelona, , Spain
Hospital de Mataro
Mataró, , Spain
Hosp. General Universitario Morales Meseguer
Murcia, , Spain
Luis Garcia Florez
Oviedo, , Spain
Skånes Universitetssjukhus, Malmo
Malmo, Sweden, Sweden
Östersund sjukhus, Kirurgiska kliniken
Östersund, Sweden, Sweden
Danderyd Sjukhus
Danderyd, , Sweden
St. Mary's Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IC-01-02-5-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.