Skeletal muscle-derived cell implantation for the treatment of fecalincontinence: a phase III, randomized, controlled, double blind, two armedclinical study. - FI-3 Fidelia

Innovacell AG0 sites290 target enrollmentAugust 3, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 3, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Innovacell AG

•1\. Patients of \>\=18 years of age
•2\. Patients willing and able to comply with the study procedures
•3\. Patients who are mentally competent and able to understand all study requirements
•4\. Patients must agree to read and sign the Informed Consent (IC) form prior to any study\-related procedures
•5\. Female patients of childbearing potential willing to use appropriate methods of contracep\-tion (see Section 8\.4\.6\.3\). Women considered of childbearing potential shall only be in\-cluded in the study after a
•confirmed menstrual period and a negative pregnancy test.
•Inclusion criteria, part 2, related to fecal incontinence:
•6\. At Screening (V1\), the patient has symptoms of urge fecal
•incontinence with a disease duration of at least 6 months but equal or less than 10 years and did not improve sufficiently by conservative treatment performed for at least 3 months
•7\. Urge fecal incontinence episodes exceeding 'traces' (as defined by the patient's diary) that occur more than twice a week

•1\. Patients who, according to the clinical judgment of the investigator, are not suitable for this study
•2\. 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
•3\. 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
•4\. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.)
•5\. Female patients who are pregnant, lactating, or intending pregnancy in the near future and female patients of childbearing potential who are not willing to use appropriate methods (see section 8\.4\.6\.3\) of contraception up to Visit 8 or who have a positive pregnancy test (only to be performed in women of childbearing potential)
•6\. 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, anorectal manometry and anal canal ultra\-sonography at the screening visit (V1\)