Actively Recruiting
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Led by Innovacell GmbH · Updated on 2025-03-12
290
Participants Needed
31
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 on anal manometry is 100mmHg or less in women and 150mmHg or less in men
- 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
You will not qualify if you...
- Patients for whom the investigator determines that fecal incontinence 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
- Patients diagnosed with HIV, acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Actively Recruiting
2
Medical University Graz
Graz, Austria
Actively Recruiting
3
Medical Center Unimed EOOD
Sevlievo, Bulgaria
Actively Recruiting
4
Fakultni nem. u sv. Anny v Brne
Brno, Brno, Czechia
Actively Recruiting
5
The Institute for the Care of Mother and Child
Prague, Czechia
Actively Recruiting
6
Deaconess Hospital Group Croix Saint - Simon
Paris, France, France, 75020
Actively Recruiting
7
Hospital Bichat - Claude Bernard
Paris, France, France, 75877
Actively Recruiting
8
CHU Rennes - Hospital Pontchaillou
Rennes, France
Actively Recruiting
9
CHU de Rouen
Rouen, France
Actively Recruiting
10
Heidelberg University, Medical Faculty Mannheim, Department of surgery
Mannheim, Germany
Actively Recruiting
11
IRCCS Ospedale San Raffaele
San Donato Milanese, Italy
Actively Recruiting
12
Hokkaido Railway Company JR Sapporo Hospital
Sapporo, Hokkaido, Japan, 060-0033
Actively Recruiting
13
Tsujinaka Hospital, Coloproctological Surgery
Chiba, Japan, 227-08771
Actively Recruiting
14
Teikyo University Chiba Medical Center
Chiba, Japan
Actively Recruiting
15
Kurume Hospital
Fukuoka, Japan, 839-0865
Actively Recruiting
16
Hiroshima Memorial Hospital
Hiroshima, Japan
Actively Recruiting
17
Meiwa Hospital
Hyōgo, Japan, 663-8186
Actively Recruiting
18
Matsushima Hospital
Kanagawa, Japan
Actively Recruiting
19
Coloproctology Center Takano Hospital
Kumamoto, Japan
Actively Recruiting
20
Japan Post Kyoto Teishin Hospital
Kyoto, Japan, 604-8798
Actively Recruiting
21
Jichi Medical University Hospital
Tochigi, Japan
Not Yet Recruiting
22
Juntendo University Hospital
Tokyo, Japan
Actively Recruiting
23
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Poland
Actively Recruiting
24
Corporacio Sanitaria Parc Tauli
Barcelona, Spain
Actively Recruiting
25
Hospital de Mataro
Mataró, Spain
Actively Recruiting
26
Hosp. General Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
27
Luis Garcia Florez
Oviedo, Spain
Actively Recruiting
28
Skånes Universitetssjukhus, Malmo
Malmö, Sweden, Sweden
Actively Recruiting
29
Östersund sjukhus, Kirurgiska kliniken
Östersund, Sweden, Sweden
Actively Recruiting
30
Danderyd Sjukhus
Danderyd, Sweden
Actively Recruiting
31
St. Mary's Hospital
London, United Kingdom
Actively Recruiting
Research Team
I
Innovacell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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