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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04976153
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Innovacell AG

Tracking Information
First Submitted Date  ICMJE July 5, 2021
First Posted Date  ICMJE July 26, 2021
Last Update Posted Date August 31, 2022
Actual Study Start Date  ICMJE May 11, 2022
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
Changes in frequency of incontinence episodes [ Time Frame: 12 Months ]
Urge fecal incontinence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Official Title  ICMJE Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urge Incontinence
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: aSMDC
    Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence
    Intervention: Biological: aSMDC
  • Placebo Comparator: Placebo
    Placebo control is the vehicle solution used for the study product
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2021)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melanie Amort-Achmüller +43512573680 office@innovacell.com
Listed Location Countries  ICMJE Bulgaria,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04976153
Other Study ID Numbers  ICMJE IC-01-02-5-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Innovacell AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Innovacell AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innovacell AG
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP