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

NCT ID: NCT03205670

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2022-06-01

Brief Summary

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.

Detailed 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.

Conditions

Urethral Stricture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Urethroplasty with a tissue-engineered construct

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.

Group Type: EXPERIMENTAL

Urethroplasty with a tissue-engineered construct

Intervention Type: PROCEDURE

The investigators will perform urethroplasty with the tissue-engineered construct - epithelial cells isolated from patient's buccal mucosa and seeded on a collagen-polylactoglycolide matrix.

Interventions

Urethroplasty with a tissue-engineered construct

The investigators will perform urethroplasty with the tissue-engineered construct - epithelial cells isolated from patient's buccal mucosa and seeded on a collagen-polylactoglycolide matrix.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Denis Butnaru, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis Butnaru, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sechenov First Moscow State Medical University

Andrey Vinarov, Dr., Prof.

Role: PRINCIPAL_INVESTIGATOR

Sechenov First Moscow State Medical University

Locations

Sechenov University

Moscow, , Russia

Countries

Russia

Other Identifiers

SU-IRM-2017-0001

Identifier Type: -

Identifier Source: org_study_id