Using muscle cells to treat fecal incontinence
Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
This study is testing if using muscle cells can help people with fecal incontinence feel better when other treatments haven’t worked.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innovacell GmbH Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 31 sites (Feldkirch and 30 other locations) |
| Trial ID | NCT04976153 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of autologous skeletal muscle-derived cells for patients suffering from urge fecal incontinence due to dysfunction of the external anal sphincter. Participants will receive either the muscle cell treatment or a placebo, and their outcomes will be assessed over time. The study focuses on individuals who have not found relief from conservative treatments and have specific measurable impairments in anal sphincter function. The goal is to determine if this innovative approach can significantly improve symptoms and quality of life for affected patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with urge fecal incontinence due to external anal sphincter dysfunction who have not responded adequately to conservative treatments.
Not a fit: Patients whose fecal incontinence is caused by factors other than external anal sphincter dysfunction may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from fecal incontinence, improving their daily functioning and quality of life.
How similar studies have performed: While this approach is innovative, similar studies using muscle-derived cells for other conditions have shown promise, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Feldkirch and 30 other locations
- Landeskrankenhaus Feldkirch — Feldkirch, Austria (Recruiting)
- Medical University Graz — Graz, Austria (Recruiting)
- Medical Center Unimed EOOD — Sevlievo, Bulgaria (Recruiting)
- Fakultni nem. u sv. Anny v Brne — Brno, Brno, Czechia (Recruiting)
- The Institute for the Care of Mother and Child — Prague, Czechia (Recruiting)
- Deaconess Hospital Group Croix Saint - Simon — Paris, France, France (Recruiting)
- Hospital Bichat - Claude Bernard — Paris, France, France (Recruiting)
- CHU Rennes - Hospital Pontchaillou — Rennes, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
- Heidelberg University, Medical Faculty Mannheim, Department of surgery — Mannheim, Germany (Recruiting)
- IRCCS Ospedale San Raffaele — San Donato Milanese, Italy (Recruiting)
- Hokkaido Railway Company JR Sapporo Hospital — Sapporo, Hokkaido, Japan (Recruiting)
- Tsujinaka Hospital, Coloproctological Surgery — Chiba, Japan (Recruiting)
- Teikyo University Chiba Medical Center — Chiba, Japan (Recruiting)
- Kurume Hospital — Fukuoka, Japan (Recruiting)
- Hiroshima Memorial Hospital — Hiroshima, Japan (Recruiting)
- Meiwa Hospital — Hyōgo, Japan (Recruiting)
- Matsushima Hospital — Kanagawa, Japan (Recruiting)
- Coloproctology Center Takano Hospital — Kumamoto, Japan (Recruiting)
- Japan Post Kyoto Teishin Hospital — Kyoto, Japan (Recruiting)
- Jichi Medical University Hospital — Tochigi, Japan (Not_yet_recruiting)
- Juntendo University Hospital — Tokyo, Japan (Recruiting)
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie — Krakow, Poland (Recruiting)
- Corporacio Sanitaria Parc Tauli — Barcelona, Spain (Recruiting)
- Hospital de Mataro — Mataró, Spain (Recruiting)
- Hosp. General Universitario Morales Meseguer — Murcia, Spain (Recruiting)
- Luis Garcia Florez — Oviedo, Spain (Recruiting)
- Skånes Universitetssjukhus, Malmo — Malmö, Sweden, Sweden (Recruiting)
- Östersund sjukhus, Kirurgiska kliniken — Östersund, Sweden, Sweden (Recruiting)
- Danderyd Sjukhus — Danderyd, Sweden (Recruiting)
- St. Mary's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Innovacell
- Email: office@innovacell.com
- Phone: +43512573680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.