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

November 20, 2023 updated by: Innovacell AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Feldkirch, Austria
        • Recruiting
        • Landeskrankenhaus Feldkirch
        • Principal Investigator:
          • Peter Tschann
        • Contact:
  • Bulgaria
      • Sevlievo, Bulgaria
        • Recruiting
        • Medical center Unimed EOOD
        • Contact:
        • Principal Investigator:
          • Minko Mihov
  • Czechia
      • Brno, Czechia
        • Recruiting
        • Fakultni nem. u sv. Anny v Brne
        • Principal Investigator:
          • Petr Vlcek
      • Prague, Czechia
        • Recruiting
        • The Institute for the Care of Mother and Child
        • Principal Investigator:
          • Vitezslav Duchac
  • France
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hospital Pontchaillou
        • Principal Investigator:
          • Laurent Siproudhis
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Principal Investigator:
          • Anne Marie Leroi
  • Germany
      • Mannheim, Germany
        • Recruiting
        • Heidelberg University, Medical Faculty Mannheim, Department of surgery
        • Contact:
        • Principal Investigator:
          • Christoph Reißfelder
  • Japan
      • Chiba, Japan
        • Not yet recruiting
        • Kameda General Hospital
        • Principal Investigator:
          • Tomoko Takahashi
      • Chiba, Japan
        • Recruiting
        • Teikyo University Chiba Medical Center
        • Principal Investigator:
          • Keiji Koda
      • Hiroshima, Japan
        • Recruiting
        • Hiroshima Memorial Hospital
        • Principal Investigator:
          • Raita Yano
      • Kanagawa, Japan
        • Recruiting
        • Matsushima Hospital
        • Principal Investigator:
          • Joji Kuromizu
      • Kumamoto, Japan
        • Recruiting
        • Coloproctology Center Takano Hospital
        • Principal Investigator:
          • Shota Takano
      • Kyoto, Japan
        • Recruiting
        • Kyoto Shinmachi Hospital
        • Principal Investigator:
          • Hirokazu Sasaki
      • Tochigi, Japan
        • Not yet recruiting
        • Jichi Medical University Hospital
        • Principal Investigator:
          • Toshiki Mimura
      • Tokyo, Japan
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Kazuhiro Sakamoto
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Laura Mora Lopez
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario de La Princesa
        • Principal Investigator:
          • Javier Garcia Septiem
      • Mataró, Spain
        • Recruiting
        • Hospital de Mataró
        • Contact:
        • Principal Investigator:
          • Pere Clave
      • Murcia, Spain
        • Recruiting
        • Hosp. General Universitario Morales Meseguer
        • Principal Investigator:
          • Victoriano Soria Aledo
      • Oviedo, Spain
        • Recruiting
        • Luis Garcia Florez
        • Contact:
        • Principal Investigator:
          • Luis Garcia Florez
  • Sweden
      • Danderyd, Sweden
        • Recruiting
        • Danderyd Sjukhus
        • Principal Investigator:
          • Susanne Müller
      • Malmö, Sweden
        • Recruiting
        • Skånes Universitetssjukhus, Malmö
        • Principal Investigator:
          • Louis Banka Johnson
      • Östersund, Sweden
        • Recruiting
        • Östersund sjukhus, Kirurgiska kliniken
        • Contact:
        • Principal Investigator:
          • Jan Lehmann
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • St. Mary's Hospital
        • Principal Investigator:
          • Alex Digesu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in frequency of incontinence episodes
Time Frame: 12 Months
Urge fecal incontinence
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovacell AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC-01-02-5-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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