Fecal incontinence MedDRA version: 20.0 Level: LLT Classification code 10016296 Term: Fecal incontinence System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10055507 Term: Fecal incontinence aggravated System Organ Class: 100000004856
Conditions
Sponsors
Innovacell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 7. Urge fecal incontinence episodes exceeding 'traces' (as defined by the patient's baseline diary) that occur more than twice a week 8. Incremental voluntary maximum squeeze pressure on anal manometry is 100mmHg or less in women and 150mmHg or less in men 9. Ultrasound of the anal canal showing the overall extent of external anal sphincter injury and tear of 180 degrees or less Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 145
Exclusion criteria
Exclusion criteria: 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 (test-ing 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 meth-ods (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, surgi-cal history, physical examination, anoscopy, anorectal manometry and anal canal ultra-sonography at the screening visit (V1) As specific exclusion: • Patients with chronic diarrhea or liquid stool that my cause fecal incontinence • Patients with rectal fecal impaction that may be the cause of overflow fecal in-continence • Patients who may have passive fecal incontinence due to rectal hypersensitivity and lack of urge to defecate • Patients in whom the cause of fecal incontinence is considered to be or cannot be excluded to be neuropathy or myelopathy • Patients with Goligher class III internal hemorrhoids (patients with Goligher class I and class II internal hemorrhoids are not excluded as they are considered not clin-ically involved in fecal incontinence) 7. Patients with global fragmentation of the external anal sphincter as assessed by anal ca-nal ultrasound 8. Patients who underwent any anorectal surgery within 6 months before screening visit 9. Patients who underwent a total of two or more external anal sphincter-related surgeries (only one repair after an obstetric injury after vaginal birth is allowed) 10. Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fis-sures 11. Patients with poorly controlled chronic constipation including obstructed defecation syn-drome 12. Patients with indications against a surgery under anesthesia 13. Patients with a malignant disease not in remission for 5 years or more 14. Patients who have undergone radiation therapy of the bowel and pelvis 15. Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis 16. Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy 17. Patients with a diagnosis of chronic inflammatory bowel disease 18. 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) 19. Patients with known hypersensitivity to any component of the product (autologous cells, Ringer's lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor [FGF]), gentamycin) 20. Patients diagnosed with human immunodeficiency virus (HIV),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of safety and efficacy of study treatment;Secondary Objective: Not applicable;Primary end point(s): Changes in frequency of incontinence episodes as measured by the incontinence diary records prior to Visit 8 compared to the baseline period from diary records prior to implan-tation Visit 3, in both treatment groups.;Timepoint(s) of evaluation of this end point: Visit 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by more than 50% under treatment. Derived from diary records prior to Visit 8 compared to the baseline period from diary records prior to implantation Visit 3. Additional secondary endpoints: 2. Frequency of response measured in both treatment arms as a reduction of the frequency of incontinence episodes by more than 50% under treatment. Derived from diary records prior to Visit 5, Visit 6, Visit 7 compared to the baseline period from diary records prior to implantation Visit 3. 3. Changes in frequency of incontinence episodes at Visit 5, Visit 6, Visit 7 compared to baseline period derived from bowel diary records prior to implantation at Visit 3 in both treatment arms. 4. Change in the CCFIS at Visit 8 compared to baseline determined before implantation at Visit 3 in both treatment arms. 5. Change in the Visual Analogue Scale (VAS) at Visit 5, Visit 6, Visit 7, Visit 8 compared to baseline period derived from bowel diary records prior to implantation at Visit 3 in both treatment arms. 6. Patient's assessment based on the Fecal Incontinence Quality of life questionnaire (FI-QoL) score at Visit 5, Visit 6, Visit 7, Visit 8 compared to baseline before implantation at Visit 3 in both treatment arms. 7. Patient's assessment based on the SF-36 questionnaire score at Visit 8 compared to baseline before implantation at Visit 3 in both treatment arms. 8. Investigator's assessment by the Clinical Global Impression (CGI) score at Visit 5, Visit 6, Visit 7, Visit 8 compared to baseline before implantation at Visit 3 in both treatment arms. 9. Patient's assessment by the Patient Global Impression (PGI) score at Visit 5, Visit 6, Visit 7, Visit 8 compared to patient's personal impression of the disease status before cell im-plantation. 10. Examinations based on the incontinence diary records. 11. Changes in anorectal manometry at Visit 8 co | — |
Countries
Austria, Bulgaria, Czechia, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Contacts
Public ContactInnovacell AG
Innovacell AG
Outcome results
None listed