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

July 9, 2026 updated by: Innovacell GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University Graz
      • Hall in Tirol, Austria, 6060
        • Recruiting
        • Landeskrankenhaus Hall in Tirol
        • Contact:
          • Gynäkologie und Geburtenhilfe Milser Straße 10
          • Phone Number: +43 50-504-363607
  • Bulgaria
      • Sevlievo, Bulgaria
        • Recruiting
        • Medical Center Unimed EOOD
        • Contact:
  • Czechia
      • Prague, Czechia
        • Recruiting
        • The Institute for the Care of Mother and Child
        • Principal Investigator:
          • Vitezslav Duchac
    • Brno
      • Brno, Brno, Czechia
        • Recruiting
        • Fakultni nem. u sv. Anny v Brne
  • France
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hospital Pontchaillou
        • Principal Investigator:
          • Laurent Siproudhis
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Principal Investigator:
          • Anne Marie Leroi
    • France
      • Paris, France, France, 75020
        • Recruiting
        • Deaconess Hospital Group Croix Saint - Simon
      • Paris, France, France, 75877
        • Recruiting
        • Hospital Bichat - Claude Bernard
  • Germany
      • Mannheim, Germany
        • Recruiting
        • Heidelberg University, Medical Faculty Mannheim, Department of surgery
        • Contact:
          • Phone Number: +496213832225
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51065
        • Recruiting
        • Magen Darm Zentrum Wiener Platz
  • Italy
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Chirurgia Colorettale
          • Phone Number: +39 02-2643-6275
    • Milano
      • San Donato Milanese, Milano, Italy
        • Recruiting
        • I.R.C.C.S. Policlinico San Donato
        • Contact:
          • Via Morandi 3 - 20097 San Donato Milanese
  • Japan
      • Chiba, Japan
        • Recruiting
        • Teikyo University Chiba Medical Center
        • Principal Investigator:
          • Keiji Koda
      • Chiba, Japan, 227-08771
        • Recruiting
        • Tsujinaka Hospital, Coloproctological Surgery
        • Principal Investigator:
          • Yukihiro Hamahata
      • Fukuoka, Japan, 839-0865
        • Recruiting
        • Kurume Hospital
        • Principal Investigator:
          • Thoshihiro Noake
      • Hiroshima, Japan
        • Recruiting
        • Hiroshima Memorial Hospital
        • Principal Investigator:
          • Raita Yano
      • Hyōgo, Japan, 663-8186
        • Recruiting
        • Meiwa Hospital
        • Principal Investigator:
          • Ryo Okamoto
      • Kanagawa, Japan
        • Recruiting
        • Matsushima Hospital
        • Principal Investigator:
          • Joji Kuromizu
      • Kumamoto, Japan
        • Recruiting
        • Coloproctology Center Takano Hospital
        • Principal Investigator:
          • Shota Takano
      • Kyoto, Japan, 604-8798
        • Recruiting
        • Japan Post Kyoto Teishin 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
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Recruiting
        • Hokkaido Railway Company JR Sapporo Hospital
        • Principal Investigator:
          • Tsuruma Tetsuhiro
  • Poland
      • Krakow, Poland
        • Recruiting
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Slovenia
    • Osrednjeslovenska
      • Ljubljana, Osrednjeslovenska, Slovenia, 1000
        • Recruiting
        • IATROS Medicinski Center
        • Contact:
          • Dr. Kosorok
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Laura Mora Lopez
      • Mataró, Spain
      • Murcia, Spain
        • Recruiting
        • Hosp. General Universitario Morales Meseguer
        • Principal Investigator:
          • Victoriano Soria Aledo
      • Oviedo, Spain
  • Sweden
      • Danderyd, Sweden
        • Recruiting
        • Danderyd Sjukhus
        • Principal Investigator:
          • Susanne Müller
    • Sweden
      • Malmö, Sweden, Sweden
        • Recruiting
        • Skånes Universitetssjukhus, Malmö
      • Östersund, Sweden, Sweden
        • Recruiting
        • Östersund sjukhus, Kirurgiska kliniken
        • Contact:
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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
  • Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men
  • 9. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees

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 (e.g Crohn's disease, Colitis Ulcerosa)
  • 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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovacell GmbH

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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