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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 : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Innovacell AG

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes in frequency of incontinence episodes [ Time Frame: 12 Months ]
    Urge fecal incontinence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976153


Contacts
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Contact: Melanie Amort-Achmüller +43512573680 office@innovacell.com

Locations
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Bulgaria
Medical Center Unimed EOOD Recruiting
Sevlievo, Bulgaria
Contact: Kiril Manolov    +359893397744    k.manolov@unimed.bg   
Principal Investigator: Minko Mihov         
Spain
Corporacio Sanitaria Parc Tauli Recruiting
Barcelona, Spain
Principal Investigator: Laura Mora Lopez         
Hospital Universitario de La Princesa Not yet recruiting
Barcelona, Spain
Principal Investigator: Javier Garcia Septiem         
Hospital Universitari Vall D'Hebron Not yet recruiting
Madrid, Spain
Contact    +34660701873    eespin@uhebron.net   
Principal Investigator: Eloy Espin-Basany         
Hospital de Mataro Recruiting
Mataró, Spain
Principal Investigator: Pere Clave         
Hosp. General Universitario Morales Meseguer Recruiting
Murcia, Spain
Principal Investigator: VICTORIANO SORIA ALEDO         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain
Principal Investigator: Luis Garcia Florez         
Hospital Universitario Virgen del Rocio Not yet recruiting
Sevilla, Spain
Contact       fportilla@us.es   
Principal Investigator: Fernando de la Portilla         
Sweden
Skånes Universitetssjukhus, Malmo Not yet recruiting
Malmö, Sweden
Principal Investigator: Louis Banka Johnson         
Östersund sjukhus, Kirurgiska kliniken Not yet recruiting
Östersund, Sweden
Principal Investigator: Jan Lehmann         
Sponsors and Collaborators
Innovacell AG
More Information
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Responsible Party: Innovacell AG
ClinicalTrials.gov Identifier: NCT04976153    
Other Study ID Numbers: IC-01-02-5-009
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fecal Incontinence
Urinary Incontinence, Urge
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations