Fecal IncontinencePhase 3FideliaNCT04976153
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
A Phase 3 study testing aSMDC in people with Fecal Incontinence, run by Innovacell GmbH at 34 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- aSMDC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 34 sitesin 12 countries
- Study dates
- 11 May 2022to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
34 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 12 countries
Japan11 sites, 11 recruiting
- Recruiting
Tsujinaka Hospital, Coloproctological Surgery
Chiba, 227-08771
Yukihiro Hamahata
- Recruiting
Teikyo University Chiba Medical Center
Chiba
Keiji Koda
- Recruiting
Kurume Hospital
Fukuoka, 839-0865
Thoshihiro Noake
- Recruiting
Hiroshima Memorial Hospital
Hiroshima
Raita Yano
- Recruiting
Meiwa Hospital
Hyōgo, 663-8186
Ryo Okamoto
- Recruiting
Matsushima Hospital
Kanagawa
Joji Kuromizu
- Recruiting
Coloproctology Center Takano Hospital
Kumamoto
Shota Takano
- Recruiting
Japan Post Kyoto Teishin Hospital
Kyoto, 604-8798
Hirokazu Sasaki
- Recruiting
Hokkaido Railway Company JR Sapporo Hospital
Sapporo, Hokkaido, 060-0033
Tsuruma Tetsuhiro
- Not yet recruiting
Jichi Medical University Hospital
Tochigi
Toshiki Mimura
- Recruiting
Juntendo University Hospital
Tokyo
Kazuhiro Sakamoto
France4 sites, 4 recruiting
- Recruiting
Deaconess Hospital Group Croix Saint - Simon
Paris, France, 75020
- Recruiting
Hospital Bichat - Claude Bernard
Paris, France, 75877
- Recruiting
CHU Rennes - Hospital Pontchaillou
Rennes
- Recruiting
CHU de Rouen
Rouen
Spain4 sites, 4 recruiting
- Recruiting
Corporacio Sanitaria Parc Tauli
Barcelona
- Recruiting
Hospital de Mataro
Mataró
Pere Clave, pere.clave@ciberehd.org
- Recruiting
Hosp. General Universitario Morales Meseguer
Murcia
- Recruiting
Luis Garcia Florez
Oviedo
Luis J Garcia Florez, +34985108000, luisjoaquin.garcia@sespa.es
Sweden3 sites, 3 recruiting
- Recruiting
Danderyd Sjukhus
Danderyd
- Recruiting
Skånes Universitetssjukhus, Malmo
Malmö, Sweden
- Recruiting
Östersund sjukhus, Kirurgiska kliniken
Östersund, Sweden
Jan Lehmann, +4663153000, Jan.Lehmann@regionjh.se
Austria2 sites, 2 recruiting
- Recruiting
Medical University Graz
Graz
- Recruiting
Landeskrankenhaus Hall in Tirol
Hall in Tirol, 6060
Gynäkologie und Geburtenhilfe Milser Straße 10, +43 50-504-363607
Czechia2 sites, 2 recruiting
- Recruiting
Fakultni nem. u sv. Anny v Brne
Brno, Brno
- Recruiting
The Institute for the Care of Mother and Child
Prague
Germany2 sites, 2 recruiting
- Recruiting
Magen Darm Zentrum Wiener Platz
Cologne, North Rhine-Westphalia, 51065
- Recruiting
Heidelberg University, Medical Faculty Mannheim, Department of surgery
Mannheim
+496213832225
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Chirurgia Colorettale, +39 02-2643-6275
- Recruiting
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milano
Via Morandi 3 - 20097 San Donato Milanese
Bulgaria1 site, 1 recruiting
- Recruiting
Medical Center Unimed EOOD
Sevlievo
Kiril Manolov, +359893397744, k.manolov@unimed.bg
Poland1 site, 1 recruiting
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow
Slovenia1 site, 1 recruiting
- Recruiting
IATROS Medicinski Center
Ljubljana, Osrednjeslovenska, 1000
Dr. Kosorok
United Kingdom1 site, 1 recruiting
- Recruiting
St. Mary's Hospital
London
About this study
Official title: 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.
- Conditions
- Fecal Incontinence
- Being tested
- aSMDC, Placebo
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aSMDCBiological
Autologous Muscle Derived Cells for injection into the external anal sphincter
PlaceboOther
Placebo control is the vehicle solution used for the study product
| Study group | Role | What they receive |
|---|---|---|
| aSMDC | Experimental | Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence Receives: Biological: aSMDC |
| Placebo | Placebo comparator | Placebo control is the vehicle solution used for the study product Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency of incontinence episodes
Urge fecal incontinence
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start11 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovacell GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976153
- Sponsor's protocol ID
- IC-01-02-5-009
- Acronym
- Fidelia
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study
- ClinicalTrials.gov ID
- NCT04976153
- Acronym / sponsor ID
- Fidelia / IC-01-02-5-009
- Conditions
- Fecal Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Innovacell GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aSMDC | Experimental | Biological: aSMDCAutologous skeletal muscle derived cells for the treatment of urge fecal incontinence |
| Placebo | Placebo comparator | Other: PlaceboPlacebo control is the vehicle solution used for the study product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aSMDCAutologous Muscle Derived Cells for injection into the external anal sphincter | Biological | aSMDC |
| PlaceboPlacebo control is the vehicle solution used for the study product | Other | Placebo |
Primary outcome
Changes in frequency of incontinence episodes
Time frame: 12 Months
Urge fecal incontinence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
34 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aSMDC in people with Fecal Incontinence, run by Innovacell GmbH at 34 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan, France, Spain, Sweden, Austria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Innovacell (+43512573680, office@innovacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency of incontinence episodes (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.