Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

— Fidelia  

Official title:

Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976153
• Other study ID #: IC-01-02-5-009
• Status: Recruiting
• Phase: Phase 3
• Start date: May 11, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: Innovacell AG
• Contact: Innovacell
• Phone: +43512573680
• Email: office[@]innovacell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: July 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Incremental voluntary maximum squeeze pressure on anal manometry is 100mmHg or less in women and 150mmHg or less in men
• Ultrasound of the anal canal showing the overall extent of external anal sphincter injury and tear of 180 degrees or less

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
• 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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Biological:
• aSMDC
Autologous Muscle Derived Cells for injection into the external anal sphincter

Other:
• Placebo
Placebo control is the vehicle solution used for the study product

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Bulgaria	Medical Center Unimed EOOD	Sevlievo
Czechia	Fakultni nem. u sv. Anny v Brne	Brno
Czechia	The Institute for the Care of Mother and Child	Prague
France	CHU Rennes - Hospital Pontchaillou	Rennes
France	CHU de Rouen	Rouen
Germany	Heidelberg University, Medical Faculty Mannheim, Department of surgery	Mannheim
Italy	IRCCS Ospedale San Raffaele	San Donato Milanese
Japan	Kameda General Hospital	Chiba
Japan	Teikyo University Chiba Medical Center	Chiba
Japan	Hiroshima Memorial Hospital	Hiroshima
Japan	Matsushima Hospital	Kanagawa
Japan	Coloproctology Center Takano Hospital	Kumamoto
Japan	Kyoto Shinmachi Hospital	Kyoto
Japan	Jichi Medical University Hospital	Tochigi
Japan	Juntendo University Hospital	Tokyo
Poland	Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie	Kraków
Spain	Corporacio Sanitaria Parc Tauli	Barcelona
Spain	Hospital de Mataro	Mataró
Spain	Hosp. General Universitario Morales Meseguer	Murcia
Spain	Luis Garcia Florez	Oviedo
Sweden	Danderyd Sjukhus	Danderyd
Sweden	Skånes Universitetssjukhus, Malmo	Malmö
Sweden	Östersund sjukhus, Kirurgiska kliniken	Östersund
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Innovacell AG

Countries where clinical trial is conducted

Austria,  Bulgaria,  Czechia,  France,  Germany,  Italy,  Japan,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of incontinence episodes	Urge fecal incontinence	12 Months