NCT04976153

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
14mo left

Started May 2022

Longer than P75 for phase_3

Geographic Reach
11 countries

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2022Jul 2027

First Submitted

Initial submission to the registry

July 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

July 5, 2021

Last Update Submit

March 10, 2025

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Changes in frequency of incontinence episodes

    Urge fecal incontinence

    12 Months

Study Arms (2)

aSMDC

EXPERIMENTAL

Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence

Biological: aSMDC

Placebo

PLACEBO COMPARATOR

Placebo control is the vehicle solution used for the study product

Other: Placebo

Interventions

aSMDCBIOLOGICAL

Autologous Muscle Derived Cells for injection into the external anal sphincter

aSMDC
PlaceboOTHER

Placebo control is the vehicle solution used for the study product

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \. 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

RECRUITING

Medical University Graz

Graz, Austria

RECRUITING

Medical Center Unimed EOOD

Sevlievo, Bulgaria

RECRUITING

Fakultni nem. u sv. Anny v Brne

Brno, Brno, Czechia

RECRUITING

The Institute for the Care of Mother and Child

Prague, Czechia

RECRUITING

Deaconess Hospital Group Croix Saint - Simon

Paris, France, 75020, France

RECRUITING

Hospital Bichat - Claude Bernard

Paris, France, 75877, France

RECRUITING

CHU Rennes - Hospital Pontchaillou

Rennes, France

RECRUITING

CHU de Rouen

Rouen, France

RECRUITING

Heidelberg University, Medical Faculty Mannheim, Department of surgery

Mannheim, Germany

RECRUITING

IRCCS Ospedale San Raffaele

San Donato Milanese, Italy

RECRUITING

Hokkaido Railway Company JR Sapporo Hospital

Sapporo, Hokkaido, 060-0033, Japan

RECRUITING

Tsujinaka Hospital, Coloproctological Surgery

Chiba, 227-08771, Japan

RECRUITING

Teikyo University Chiba Medical Center

Chiba, Japan

RECRUITING

Kurume Hospital

Fukuoka, 839-0865, Japan

RECRUITING

Hiroshima Memorial Hospital

Hiroshima, Japan

RECRUITING

Meiwa Hospital

Hyōgo, 663-8186, Japan

RECRUITING

Matsushima Hospital

Kanagawa, Japan

RECRUITING

Coloproctology Center Takano Hospital

Kumamoto, Japan

RECRUITING

Japan Post Kyoto Teishin Hospital

Kyoto, 604-8798, Japan

RECRUITING

Jichi Medical University Hospital

Tochigi, Japan

NOT YET RECRUITING

Juntendo University Hospital

Tokyo, Japan

RECRUITING

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

RECRUITING

Corporacio Sanitaria Parc Tauli

Barcelona, Spain

RECRUITING

Hospital de Mataro

Mataró, Spain

RECRUITING

Hosp. General Universitario Morales Meseguer

Murcia, Spain

RECRUITING

Luis Garcia Florez

Oviedo, Spain

RECRUITING

Skånes Universitetssjukhus, Malmo

Malmo, Sweden, Sweden

RECRUITING

Östersund sjukhus, Kirurgiska kliniken

Östersund, Sweden, Sweden

RECRUITING

Danderyd Sjukhus

Danderyd, Sweden

RECRUITING

St. Mary's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Innovacell

CONTACT

+43512573680office@innovacell.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 26, 2021

Study Start

May 11, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

FR(4)SE(3)GB(1)IT(1)ES(4)AU(2)CZ(2)BU(1)DE(1)JP(11)PL(1)