Efficacy and safety of a tissue-engineered mouth mucosa (MukoCell®) vs. untreated mouth mucosa for the reconstruction of urethra in male patients with urethral stricture

Phase 1

• Conditions: rethral stricture; MedDRA version: 26.0Level: LLTClassification code 10046466Term: Urethral strictureSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2018-003532-71-DE
• Lead Sponsor: MukoCell GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

1.Signed declaration of consent and data protection declaration obtained prior to any trial-specific procedures
2.Male patient aged =18 and =75 years
3.Urethral stricture fulfilling the following criteria:
- Medical need for urethroplasty
- Located pre-dominantly bulbar
- No more than 3 previous urethrotomies

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Any urethroplasty in the past
2.Presence of solely penile stricture
3.Penile /urethral abnormality (e.g. hypospadia, penile curvature, etc.) interfering with study related assessments
4.Lichen sclerosis
5Previous radiation therapy or laser treatment of the urethral region
6.Acute or chronic urethritis, presence of balanitis
7.Acute or chronic infections in the oral cavity
8.Presence of urologic disease(s) interfering with urination
9.Concomitant therapy with medications that may lead to urinary retention (e.g. anticholinergics etc.)
10.Severe liver or kidney disease
11.Severe somatopathic, neurological and /or psychiatric disease(s)
12.Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before the Screening visit)

Study & Design

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