Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers

An Open Prospective Clinical Study on Safety and Efficacy of Surgical Treatment of Patients With Anterior Urethral Stricture Using a Tissue-engineered Construct Based on Autologous Buccal Mucosa Cells and Matrix From Reconstituted Collagen and Reinforcing Polylactoglycolide Fibers

This study investigates safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct based on autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This is a single arm study with no control. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at five years.

Treatment of urethral strictures longer than 2 cm is an actual clinical challenge. In this case, the common method is replacement surgery using a buccal mucosa graft. However, the main disadvantage of this method is associated with limited donor resources and donor site morbidity.

The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct. The construct consists of autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. Patients will be followed up for 5 years within this study. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, biopsy, and quality of life monitoring. Telephone follow-up will take place in between these assessments.

The data obtained from this study will have practical implications for the urethral stricture treatment and will be based on the principles of evidence-based medicine.

Inclusion Criteria:

• Patient signed informed consent form
• Diagnosed anterior urethral stricture longer than 2.0 cm and shorter than 4.0 cm
• At least one prior internal optical urethrotomy and/or urethral bougienage

Non-inclusion Criteria:

• Acute infectious diseases
• Patient with decompensated heart and renal failure
• Patient with non-compensated diabetes mellitus
• Patient with malignant tumor
• Patient with polyvalent allergy
• Mental disorders
• Post traumatic urethral strictures
• Subtotal and total urethral strictures
• Sexually transmitted infections
• Hypersensitivity to any components of tissue-engineered constructs
• Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
• Other associated urethral strictures
• Laboratory markers of active urethritis

Exclusion Criteria:

• Patient's refusal from the further participation in trial
• Confirmed syphilis, HIV, hepatitis B or C infections
• Patient who cannot be regularly examined due to any circumstances