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History of Changes for Study: NCT04976153
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence (Fidelia)
Latest version (submitted November 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 14, 2021 None (earliest Version on record)
2 March 29, 2022 Study Status
3 May 31, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 June 24, 2022 Contacts/Locations and Study Status
5 August 17, 2022 Contacts/Locations and Study Status
6 August 29, 2022 Contacts/Locations and Study Status
7 September 28, 2022 Contacts/Locations and Study Status
8 November 16, 2022 Contacts/Locations and Study Status
9 November 24, 2022 Eligibility, Conditions and Study Status
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Study NCT04976153
Submitted Date:  July 14, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: IC-01-02-5-009
Brief Title: Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence (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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2021
Overall Status: Not yet recruiting
Study Start: October 31, 2021
Primary Completion: October 31, 2023 [Anticipated]
Study Completion: February 28, 2024 [Anticipated]
First Submitted: July 5, 2021
First Submitted that
Met QC Criteria:
July 14, 2021
First Posted: July 26, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
July 14, 2021
Last Update Posted: July 26, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Innovacell AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Urge Incontinence
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 290 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Placebo
Placebo control is the vehicle solution used for the study product
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Changes in frequency of incontinence episodes
[ Time Frame: 12 Months ]

Urge fecal incontinence
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Melanie Amort-Achm├╝ller
Telephone: +43512573680
Email: melanie.amort-achmueller@innovacell.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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