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

I.M. Sechenov First Moscow State Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Urethral Stricture

Treatments: Procedure: Urethroplasty with a tissue-engineered construct

Study type: Interventional

Funder types: Other

Identifiers

NCT03205670

SU-IRM-2017-0001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Urethroplasty with a tissue-engineered construct

Experimental group

Description:

The investigators will take a sample of the buccal mucosa to isolate epithelial cells. Autologous cells will be seeded on a hybrid matrix. Urethroplasty with this tissue-engineered construct will be performed. This is a single arm study with no control. All patients will undergo the surgical operation.

Treatment:

Procedure: Urethroplasty with a tissue-engineered construct