RecruitingPhase 3NCT04976153

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

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

Sponsor

Innovacell GmbH

Enrollment

290 participants

Start Date

May 11, 2022

Study Type

INTERVENTIONAL

Conditions

Fecal Incontinence

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a biological treatment called aSMDC for people with fecal incontinence. The study is currently recruiting participants at 34 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALaSMDC

Autologous Muscle Derived Cells for injection into the external anal sphincter

OTHERPlacebo

Placebo control is the vehicle solution used for the study product

Locations(34)

Medical University Graz

Graz, Austria

Landeskrankenhaus Hall in Tirol

Hall in Tirol, Austria

Medical Center Unimed EOOD

Sevlievo, Bulgaria

Fakultni nem. u sv. Anny v Brne

Brno, Brno, Czechia

The Institute for the Care of Mother and Child

Prague, Czechia

Deaconess Hospital Group Croix Saint - Simon

Paris, France, France

Hospital Bichat - Claude Bernard

Paris, France, France

CHU Rennes - Hospital Pontchaillou

Rennes, France

CHU de Rouen

Rouen, France

Magen Darm Zentrum Wiener Platz

Cologne, North Rhine-Westphalia, Germany

Heidelberg University, Medical Faculty Mannheim, Department of surgery

Mannheim, Germany

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milano, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Hokkaido Railway Company JR Sapporo Hospital

Sapporo, Hokkaido, Japan

Tsujinaka Hospital, Coloproctological Surgery

Chiba, Japan

Teikyo University Chiba Medical Center

Chiba, Japan

Kurume Hospital

Fukuoka, Japan

Hiroshima Memorial Hospital

Hiroshima, Japan

Meiwa Hospital

Hyōgo, Japan

Matsushima Hospital

Kanagawa, Japan

Coloproctology Center Takano Hospital

Kumamoto, Japan

Japan Post Kyoto Teishin Hospital

Kyoto, Japan

Jichi Medical University Hospital

Tochigi, Japan

Juntendo University Hospital

Tokyo, Japan

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

IATROS Medicinski Center

Ljubljana, Osrednjeslovenska, Slovenia

Corporacio Sanitaria Parc Tauli

Barcelona, Spain

Hospital de Mataro

Mataró, Spain

Hosp. General Universitario Morales Meseguer

Murcia, Spain

Luis Garcia Florez

Oviedo, Spain

Skånes Universitetssjukhus, Malmo

Malmö, Sweden, Sweden

Östersund sjukhus, Kirurgiska kliniken

Östersund, Sweden, Sweden

Danderyd Sjukhus

Danderyd, Sweden

St. Mary's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04976153

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