Fidelia: Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

• Sponsor: Innovacell AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04976153
• Collaborator: (none)
• Enrollment: 290
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 27.7
• Patients Per Site: 29
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urge Incontinence	Biological: aSMDC; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
• Actual Study Start Date: May 11, 2022
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aSMDC Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence	Biological: aSMDC; Autologous Muscle Derived Cells for injection into the external anal sphincter
Placebo Comparator: Placebo Placebo control is the vehicle solution used for the study product	Other: Placebo; Placebo control is the vehicle solution used for the study product

Outcome Measures

Primary Outcome Measures

1. Changes in frequency of incontinence episodes [12 Months]

   Urge fecal incontinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center Unimed EOOD	Sevlievo		Bulgaria
2	Corporacio Sanitaria Parc Tauli	Barcelona		Spain
3	Hospital Universitario de La Princesa	Barcelona		Spain
4	Hospital Universitari Vall D'Hebron	Madrid		Spain
5	Hospital de Mataro	Mataró		Spain
6	Hosp. General Universitario Morales Meseguer	Murcia		Spain
7	Hospital Universitario Central de Asturias	Oviedo		Spain
8	Hospital Universitario Virgen del Rocio	Sevilla		Spain
9	Skånes Universitetssjukhus, Malmo	Malmö		Sweden
10	Östersund sjukhus, Kirurgiska kliniken	Östersund		Sweden

Sponsors and Collaborators

• Innovacell AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovacell AG
• ClinicalTrials.gov Identifier: NCT04976153
• Other Study ID Numbers: IC-01-02-5-009
• First Posted: Jul 26, 2021
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fecal Incontinence; Urinary Incontinence, Urge

Study Results

No Results Posted as of Aug 18, 2022