A clinical trial comparing muscle cell treatment with placebo in fecalincontinence patients

Phase 1

• Conditions: Fecal incontinence; MedDRA version: 20.0Level: LLTClassification code 10016296Term: Fecal incontinenceSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: LLTClassification code 10055507Term: Fecal incontinence aggravatedSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-001376-42-AT
• Lead Sponsor: Innovacell GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-13
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 290

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 contraception (see Section 8.4.6.3). Women considered of childbearing potential shall only be included 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
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

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)
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 hyposensitivity 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 clinically involved in fecal incontinence)
7. Patients with global fragmentation of the external anal sphincter as assessed by anal canal 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 fissures
11. Patients with poorly controlled chronic constipation including obstructed defecation syndrome
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
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]), gentamicin)
20. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic v

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified