Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-finding clinical study - STEFFI

Innovacell Biotechnologie AG0 sites252 target enrollmentMarch 21, 2011

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patients of \> or \= 18 years of age,
•2\. Patients suffering from FI for more than 6 months, which is confirmed at screening by relevant medical history and anorectal examination,
•3\. Patients with Wexner score \>9 and with at least 3 episodes of FI per week as measured in the bowel diary prior to Visit \-1,
•4\. Patients with no indications against a surgery under anesthesia,
•5\. Patients willing and able to comply with the study procedures,
•6\. Patients who are mentally competent and able to understand all study requirements,
•7\. Patients must agree to read and sign the Informed Consent (IC) form prior to any study\-related procedures,
•8\. Female patients of childbearing potential willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
•Interim Inclusion Criterion:
•Patients with a minimum of 3 non\-gaseous incontinence episodes per week measured using the diary during the 2 weeks prior to visit \-1 (day \-70\) (diary distributed at screening visit)

•1\. Patients with pathological findings considered clinically relevant by the Investigator (excluding sphincter damage) based on rectoscopy and ultrasound at the screening visit (e.g. grade I haemorrhoids would be considered acceptable),
•2\. Patients who have undergone any anorectal surgery within the last 6 months prior to screening visit,
•3\. Patients with more than one overlap repair surgery,
•4\. Patients with more than 2 anorectal surgical procedures (in total) e.g.
•\- primary repair after delivery and one overlap repair later\-on,
•\- in\- and explantation of a permanent neurostimulation system,
•5\. Patients with overlap repair and associated early atrophy of external anal sphincter,
•6\. Patients with a history of artificial anal sphincter surgery,
•7\. Patients with trans\- or perianal injection of any bulking products,
•8\. Patients with a malignant disease not in remission for 5 years or more,