Clinical trial • Phase III • Musculoskeletal

ICEF15 (autologous Skeletal Derived Muscle Cells - aSMDC) for Fecal incontinence

Phase III trial of ICEF15 (autologous Skeletal Derived Muscle Cells - aSMDC) for Fecal incontinence.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Fecal incontinence
Trial Stage
Phase III
Drug Modality
Cell therapy | Other

Key dates

Initial CTIS Submission Date
10-01-2025
First CTIS Authorization Date
30-01-2025

Trial design

Randomised, placebo (intramuscular solution for injection). placebo product name: placebo; route intramuscular; no specific dose or schedule detailed in the ctis metadata.-controlled Phase III trial in Bulgaria, Sweden, Spain and others.

Randomised
Yes
Comparator
Placebo (intramuscular solution for injection). Placebo product name: PLACEBO; route intramuscular; no specific dose or schedule detailed in the CTIS metadata.
Target Sample Size
60
Trial Duration For Participant
457

Eligibility

Recruits 60 Vulnerable-population considerations: the protocol requires participants to be mentally competent and able to understand all study requirements and to provide written informed consent prior to any study procedures. Subjects deprived of their liberty, admitted to social institutions or under legal protection, hospitalized without consent, or in emergency situations are explicitly excluded. Country- and language-specific informed consent documents are provided (multiple local-language ICFs listed in the trial documents). No assent procedures for minors are defined because enrollment is restricted to adults (≥18 years)..

Pregnancy Exclusion
Female patients who are pregnant, lactating, or intending pregnancy in the study and female patients of childbearing potential who are not willing to use appropriate methods of contraception (see Section 8.4.6.3) up to Visit 8. or who have a positive pregnancy test (only to be performed in women of childbearing potential)
Vulnerable Population
Vulnerable-population considerations: the protocol requires participants to be mentally competent and able to understand all study requirements and to provide written informed consent prior to any study procedures. Subjects deprived of their liberty, admitted to social institutions or under legal protection, hospitalized without consent, or in emergency situations are explicitly excluded. Country- and language-specific informed consent documents are provided (multiple local-language ICFs listed in the trial documents). No assent procedures for minors are defined because enrollment is restricted to adults (≥18 years).

Inclusion criteria

  • {"criterion_text":"- Part 1 General: Patients of ≥18 years of age\n- Patients willing and able to comply with the study procedures\n- Patients who are mentally competent and able to understand all study requirements\n- Patients must agree to read and sign the Informed Consent (IC) form prior to any studyrelated procedures\n- Female patients of childbearing potential willing to use appropriate methods of contraception (see Section 8.4.6.3). Women considered of childbearing potential shall only be included in the study after a confirmed menstrual period and a negative pregnancy test.\n- Part 2 Related to fecal incontinence: At Screening (V1), the patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months but equal to or less than 10 years, and did not improve sufficiently by conservative treatment performed for at least 3 months\n- Urge fecal incontinence episodes exceeding ”traces” (as defined by the patient’s diary) that occur more than twice a week\n- Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry of 100 mmHg or less in women and 150 mmHg or less in men\n- 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

  • {"criterion_text":"- Part 1 General: Patients who, according to the clinical judgment of the investigator, are not suitable for this study\n- Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency situation\n- Patients who are currently participating or have participated in another clinical study (testing a medical device or drug) within 30 days prior to screening Visit 1 in this study or have previously participated in this study\n- Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.)\n- Female patients who are pregnant, lactating, or intending pregnancy in the study and female patients of childbearing potential who are not willing to use appropriate methods of contraception (see Section 8.4.6.3) up to Visit 8. or who have a positive pregnancy test (only to be performed in women of childbearing potential)\n- Part 2 Related to fecal incontinence: Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. This evaluation is based on the current medical history, surgical history physical examination, anoscopy / rectoscopy, anorectal manometry, and anal canal ultrasonography at the screening visit (V1) As specific exclusion: • Patients with chronic diarrhea or liquid stool that my cause fecal incontinence • Patients with rectal fecal impaction that may be the cause of overflow fecal incontinence • Patients who may have passive fecal incontinence due to rectal hyposensitivity and lack of urge to defecate • Patients in whom the cause of fecal incontinence is considered to be or cannot be excluded to be neuropathy or myelopathy • Patients with Goligher class III internal hemorrhoids (patients with Goligher class I and class II internal hemorrhoids are not excluded as they are considered not clinically involved in fecal incontinence)\n- Patients with a diagnosis of chronic inflammatory bowel disease (e.g. Crohn’s disease, Colitis Ulcerosa)\n- Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons\n- Patients with known hypersensitivity to any component of the product (autologous cells, Ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor (FGF), gentamicin)\n- Patients with indications against a surgery under anesthesia (biopsy/implantation-specific)\n- Part 4 Cell therapy-specific: Patients with a malignant disease not in remission for 5 years or more\n- Patients who have undergone radiation therapy of the bowel and pelvis\n- Patients who have undergone chemotherapy within the last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis\n- Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy\n- Patients with a diagnosis of any kind of skeletal muscle-disease and/or neuronal disorders\n- Part 5 Related to electrical stimulation: Patients with severe myocardial disorders, irregular pulse or a pacemaker\n- Patients with implantations of metal components in the electrical stimulation treatment area\n- Defects of the skin and mucous membranes (injuries, ulcerations) and acute inflammation of the mucous membranes, skin or subcutaneous tissue in the treatment area\n- Metal implants in the field of treatment\n- Bleeding in the treatment area\n- Known mental illnesses, cognitive disorders\n- Part 6 Other: Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain\n- Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment\n- Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound\n- Patients who underwent any anorectal surgery within 6 months before screening visit\n- Patients who underwent a total of two or more external anal sphincter-related surgeries (only one repair after an obstetric injury after vaginal birth is allowed)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Changes in frequency of incontinence episodes as measured by the bowel diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92), in both treatment groups.","definition_or_measurement_approach":"Change measured from patient bowel diary entries: comparison of diary-recorded frequency of incontinence episodes prior to Visit 8 (target day 457) versus baseline diary period prior to implantation Visit 3 (target day 92) in both treatment arms."}

Secondary endpoints

  • {"endpoint_text":"- Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by ≥ 50% under treatment. Derived from diary records prior to Visit 8 (target day 457) compared to the baseline period from diary records prior to implantation Visit 3 (target day 92).","definition_or_measurement_approach":"Responder frequency defined as ≥50% reduction in incontinence episode frequency from baseline (diary before implantation Visit 3, target day 92) to pre-Visit 8 (target day 457) using patient bowel diary records."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include website/campaign materials and direct-to-patient (DTP) participant journey emails; ePRO guidance and digital patient diary materials are included (country-specific digital materials present).
Planned Sample Size
60
Recruitment Window Months
43
Consent Approach
Informed consent must be provided in writing by the participant (patients ≥18 years). Inclusion criteria require mentally competent participants able to understand study requirements and to read and sign the Informed Consent form prior to any study procedures. Country- and language-specific informed consent forms are provided (documents include ICFs in English and local languages: e.g. EN, BG, SWE, ES, IT, CZ, PL, FR, DE, SL, AT). No assent for minors (minors excluded). Additional optional/data-protection ICFs (where listed) are provided where applicable.

Methods

  • Website and campaign material (country-specific websites/campaign PDFs are listed per country e.g. DE, SWE, ES, IT, CZ, PL, AT, BG, SL, FR) – online outreach to potential patients.
  • Direct-to-patient (DTP) Participant Journey Emails (country-specific templates: e.g. DE, SWE, ES, IT, CZ, PL, AT, BG) – email communications to prospects/patients.
  • Traditional advertising content (flyers, brochures, posters) and GP/physician referral letters – country-specific materials are listed in the recruitment documents.
  • Marketing and outreach materials (country-specific marketing and outreach PDFs) – coordinated local campaigns.
  • Physician referral pathway (Physician Referral Letters and GP letters included in document set) – recruitment via clinician referral.

Geography

Total Number Of Sites
27
Total Number Of Participants
226

Bulgaria

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
468
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
UNIMED Medical Center EOOD
Principal Investigator Name
Minko Mihov
Principal Investigator Email
mihov_gb@abv.bg
Contact Person Name
Minko Mihov
Contact Person Email
mihov_gb@abv.bg

Sweden

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
467
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Region Jaemtland Haerjedalen
Department Name
Surgical Department
Principal Investigator Name
Jan Lehmann
Principal Investigator Email
jan.lehmann@regionjh.se
Contact Person Name
Jan Lehmann
Contact Person Email
jan.lehmann@regionjh.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
General Surgery
Principal Investigator Name
Ursula Aho Fält
Principal Investigator Email
Ursula.falt@skane.se
Contact Person Name
Ursula Aho Fält
Contact Person Email
Ursula.falt@skane.se
Site Name
Danderyds Sjukhus AB
Department Name
Department of OBGYN
Principal Investigator Name
Susanne Müller
Principal Investigator Email
susanne.muller@regionstockholm.se
Contact Person Name
Susanne Müller

Spain

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
468
Number Of Sites
6
Number Of Participants
50

Sites

Site Name
Hospital General Universitario Morales Meseguer
Department Name
General and Digestive Surgery
Principal Investigator Name
Victor Soria Aledo
Principal Investigator Email
victoriano.soria@carm.es
Contact Person Name
Victor Soria Aledo
Contact Person Email
victoriano.soria@carm.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
General Surgery
Principal Investigator Name
Eloy Espín Basany
Principal Investigator Email
eespin@vhebron.net
Contact Person Name
Eloy Espín Basany
Contact Person Email
eespin@vhebron.net
Site Name
Hospital Universitario Central De Asturias
Department Name
General and Digestive Surgery
Principal Investigator Name
Luis Joaquin Garcia Florez
Principal Investigator Email
garciafluis@uniov.es
Contact Person Name
Luis Joaquin Garcia Florez
Contact Person Email
garciafluis@uniov.es
Site Name
Hospital Universitario De La Princesa
Department Name
General Surgery
Principal Investigator Name
Javier Garcia Septiem
Principal Investigator Email
jgsetiem@gmail.com
Contact Person Name
Javier Garcia Septiem
Contact Person Email
jgsetiem@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Department of Surgery
Principal Investigator Name
Mariana Caraballo Angeli
Principal Investigator Email
aa.aa@aa.aa
Contact Person Name
Mariana Caraballo Angeli
Contact Person Email
aa.aa@aa.aa
Site Name
Consorci Sanitari Del Maresme
Department Name
Unidad de Motilidad Digestiva
Principal Investigator Name
Pere Clavè Civit
Principal Investigator Email
pere.clave@ciberehd.org
Contact Person Name
Pere Clavè Civit
Contact Person Email
pere.clave@ciberehd.org

Slovenia

Earliest CTIS Part Ii Submission Date
05-06-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
334
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Iatros - Dr. Kosorok d.o.o.
Department Name
Medizinski center
Principal Investigator Name
Valentin Sojar
Principal Investigator Email
info@iatros.si
Contact Person Name
Valentin Sojar
Contact Person Email
info@iatros.si

Germany

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
468
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Heidelberg University
Department Name
Department of Surgery
Principal Investigator Name
Christoph Reißfelder
Principal Investigator Email
christoph.reissfelder@umm.de
Contact Person Name
Christoph Reißfelder
Contact Person Email
christoph.reissfelder@umm.de
Site Name
Magen darm Zentrum Wiener Platz
Department Name
Department of Surgery
Principal Investigator Name
Martin Kowallik
Principal Investigator Email
post@mdz-koeln.de
Contact Person Name
Martin Kowallik
Contact Person Email
post@mdz-koeln.de

Czechia

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
467
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
The Institute For The Care Of Mother And Child
Department Name
Clinic of Surgery
Principal Investigator Name
Vítězslav Ducháč
Principal Investigator Email
vitezslav.duchac@gmail.com
Contact Person Name
Vítězslav Ducháč
Contact Person Email
vitezslav.duchac@gmail.com
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Department of Surgery
Principal Investigator Name
Petr Vlcek
Principal Investigator Email
petr.vlcek@fnusa.cz
Contact Person Name
Petr Vlcek
Contact Person Email
petr.vlcek@fnusa.cz

Italy

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
468
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
San Raffaele Hospital
Department Name
Colorectal surgery Unit
Principal Investigator Name
Pierpaolo Sileri
Principal Investigator Email
sileri.pierpaolo@hsr.it
Contact Person Name
Pierpaolo Sileri
Contact Person Email
sileri.pierpaolo@hsr.it
Site Name
Policlinico San Donato S.p.A.
Department Name
ColoProctological and Pelvic Floor Surgery Unit
Principal Investigator Name
Angelo Stuto
Principal Investigator Email
angelo.stuto@grupposandonato.it
Contact Person Name
Angelo Stuto
Site Name
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali
Department Name
Surgery and Urology
Principal Investigator Name
Mauro Cervigni
Principal Investigator Email
info@maurocervigni.it
Contact Person Name
Mauro Cervigni
Contact Person Email
info@maurocervigni.it

France

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
467
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Department of Proctology and Gastroenterology
Principal Investigator Name
Laurent Abramowitz
Principal Investigator Email
laurent.abramowitz@aphp.fr
Contact Person Name
Laurent Abramowitz
Contact Person Email
laurent.abramowitz@aphp.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Department of digestive, urinary, respiratory and sports physiology
Principal Investigator Name
Anne-Marie Leroi
Principal Investigator Email
anne-marie.leroi@chu-rouen.fr
Contact Person Name
Anne-Marie Leroi
Contact Person Email
anne-marie.leroi@chu-rouen.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Department of Proctology
Principal Investigator Name
Isabelle Etienney
Principal Investigator Email
CourrielIEtienney@hopital-dcss.org
Contact Person Name
Isabelle Etienney
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Digestive Diseases Department
Principal Investigator Name
Laurent Siproudhis
Principal Investigator Email
laurent.siproudhis@chu-rennes.fr
Contact Person Name
Laurent Siproudhis

Poland

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
468
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Surgery department
Principal Investigator Name
Piotr Wałęga
Principal Investigator Email
gabinet.walega@gmail.com
Contact Person Name
Piotr Wałęga
Contact Person Email
gabinet.walega@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
463
Number Of Sites
4
Number Of Participants
50

Sites

Site Name
Medical University Of Graz
Department Name
Department of Gynecology
Principal Investigator Name
Andrea Frudinger
Principal Investigator Email
andrea.frudinger@medunigraz.at
Contact Person Name
Andrea Frudinger
Contact Person Email
andrea.frudinger@medunigraz.at
Site Name
Tirol Kliniken GmbH
Department Name
Departement of Gynecology and Obstetrics
Principal Investigator Name
Peter Widschwendter
Principal Investigator Email
peter.widschwendter@tirol-kliniken.at
Contact Person Name
Peter Widschwendter
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department of Gynecology and Obstetrics
Principal Investigator Name
Ayman Tammaa
Principal Investigator Email
ayman.tammaa@gesundheitsverbund.at
Contact Person Name
Ayman Tammaa
Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
General, Visceral and Thoracic Surgery
Principal Investigator Name
Markus Philipp Weigl
Principal Investigator Email
markus.weigl@lkhf.at
Contact Person Name
Markus Philipp Weigl
Contact Person Email
markus.weigl@lkhf.at

Sponsor

Primary sponsor

Full Name
Innovacell GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Austria

Contract research organisations

Name
Opis S.r.l.
Responsibilities
Contract negotiation, Medical writing for CSR (and other sponsor duties as listed in the CTIS record)
Name
Probando GmbH
Responsibilities
Patient recruitment
Name
SGS Analytics Germany GmbH
Responsibilities
Laboratory/testing duties (sponsor duty code 4 listed)

Third parties

  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"Multiple sponsor duties (codes listed); explicit value entry: \"Contract negotiation, Medical writing for CSR\" (additional sponsor duties present in record).","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"SGS Analytics Germany GmbH","duties_or_roles":"Sponsor duty code: 4 (as listed in CTIS third-party duties).","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Austria","full_name":"Probando GmbH","duties_or_roles":"Patient recruitment","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
ICEF15
Active Substance
ICEF15 (autologous Skeletal Derived Muscle Cells - aSMDC)
Modality
Cell therapy
Routes Of Administration
Intramuscular use
Route
Intramuscular
Authorisation Status
Investigational (IMP in this clinical study)
Starting Dose
ICEF15 containing (50 ± 10) x 10^6 cells (aSMDC) (as per arm description)
Investigational Product Name
PLACEBO
Active Substance
PLACEBO
Modality
Other
Routes Of Administration
Intramuscular use
Route
Intramuscular
Authorisation Status
Investigational (placebo comparator in study)

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