Clinical trial NCT04976153: Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Official title: Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fecal Incontinence
Lead sponsor: Innovacell AG
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Changes in frequency of incontinence episodes
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Medical University Graz
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
city: Brno
country: Czechia
facility: Fakultni nem. u sv. Anny v Brne
city: Prague
country: Czechia
facility: The Institute for the Care of Mother and Child
city: Paris
country: France
facility: Deaconess Hospital Group Croix Saint - Simon
city: Paris
country: France
facility: Hospital Bichat - Claude Bernard
city: Rennes
country: France
facility: CHU Rennes - Hospital Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen
city: Mannheim
country: Germany
facility: Heidelberg University, Medical Faculty Mannheim, Department of surgery
city: San Donato Milanese
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Sapporo
country: Japan
facility: Hokkaido Railway Company JR Sapporo Hospital
state: Hokkaido
city: Chiba
country: Japan
facility: Tsujinaka Hospital, Coloproctological Surgery
city: Chiba
country: Japan
facility: Teikyo University Chiba Medical Center
city: Fukuoka
country: Japan
facility: Kurume Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Memorial Hospital
city: Hyogo
country: Japan
facility: Meiwa Hospital
city: Kanagawa
country: Japan
facility: Matsushima Hospital
city: Kumamoto
country: Japan
facility: Coloproctology Center Takano Hospital
city: Kyoto
country: Japan
facility: Japan Post Kyoto Teishin Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
city: Barcelona
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Mataró
country: Spain
facility: Hospital de Mataro
city: Murcia
country: Spain
facility: Hosp. General Universitario Morales Meseguer
city: Oviedo
country: Spain
facility: Luis Garcia Florez
city: Danderyd
country: Sweden
facility: Danderyd Sjukhus
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus, Malmo
city: Östersund
country: Sweden
facility: Östersund sjukhus, Kirurgiska kliniken
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References: