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

Who is this study for? Patients with Urge Incontinence
What treatments are being studied? Autologous Muscle Derived Cells
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Landeskrankenhaus Feldkirch
RECRUITING
Feldkirch
Medical University Graz
RECRUITING
Graz
Bulgaria
Medical Center Unimed EOOD
RECRUITING
Sevlievo
France
Deaconess Hospital Group Croix Saint - Simon
RECRUITING
Paris
Hospital Bichat - Claude Bernard
RECRUITING
Paris
CHU Rennes - Hospital Pontchaillou
RECRUITING
Rennes
CHU de Rouen
RECRUITING
Rouen
Germany
Heidelberg University, Medical Faculty Mannheim, Department of surgery
RECRUITING
Mannheim
Italy
IRCCS Ospedale San Raffaele
RECRUITING
San Donato Milanese
Japan
Teikyo University Chiba Medical Center
RECRUITING
Chiba
Tsujinaka Hospital, Coloproctological Surgery
RECRUITING
Chiba
Kurume Hospital
RECRUITING
Fukuoka
Hiroshima Memorial Hospital
RECRUITING
Hiroshima
Meiwa Hospital
RECRUITING
Hyōgo
Matsushima Hospital
RECRUITING
Kanagawa
Coloproctology Center Takano Hospital
RECRUITING
Kumamoto
Japan Post Kyoto Teishin Hospital
RECRUITING
Kyoto
Hokkaido Railway Company JR Sapporo Hospital
RECRUITING
Sapporo
Jichi Medical University Hospital
NOT_YET_RECRUITING
Tochigi
Juntendo University Hospital
RECRUITING
Tokyo
Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
Spain
Corporacio Sanitaria Parc Tauli
RECRUITING
Barcelona
Hospital de Mataro
RECRUITING
Mataró
Hosp. General Universitario Morales Meseguer
RECRUITING
Murcia
Luis Garcia Florez
RECRUITING
Oviedo
Sweden
Danderyd Sjukhus
RECRUITING
Danderyd
Skånes Universitetssjukhus, Malmo
RECRUITING
Malmo
Östersund sjukhus, Kirurgiska kliniken
RECRUITING
Östersund
United Kingdom
St. Mary's Hospital
RECRUITING
London
Contact Information
Primary
Innovacell
office@innovacell.com
+43512573680
Time Frame
Start Date: 2022-05-11
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 290
Treatments
Experimental: aSMDC
Autologous skeletal muscle derived cells for the treatment of urge fecal incontinence
Placebo_comparator: Placebo
Placebo control is the vehicle solution used for the study product
Related Therapeutic Areas
Sponsors
Leads: Innovacell GmbH

This content was sourced from clinicaltrials.gov