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

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03205670
• Other study ID #: SU-IRM-2017-0001
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: June 1, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Russian Federation	Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse events	Frequency, type and severity of serious adverse events (SAE)	4 weeks after surgery
Primary	Serious adverse reactions	Frequency, type and severity of serious adverse reactions (SAR)	4 weeks after surgery
Secondary	Retrograde urethrography	Influence of the surgery on the urethral lumen	5 years
Secondary	Voiding cystourethrography	Full assessment of the urethral lumen after the surgery	5 years
Secondary	Pericatheter urethrography	Assessment of absence or presence of contrast medium leakage outside the urethra	4 weeks after surgery
Secondary	Biopsy	Control of anatomical urethral structure in the intervention place	4 months after surgery
Secondary	Urodynamic changes via uroflowmetry - 1	Influence of the surgery on urinary flow rate: maximum flow rate	5 years
Secondary	Urodynamic changes via uroflowmetry - 2	Influence of the surgery on urinary flow rate: average flow rate	5 years
Secondary	Urodynamic changes via uroflowmetry - 3	Influence of the surgery on urinary flow rate: total volume voided	5 years
Secondary	Urodynamic changes via uroflowmetry - 4	Influence of the surgery on urinary flow rate: maximum flow time	5 years
Secondary	Quality of life monitoring - 1	Quality of life estimated by validated questionnaires: Short Form (SF-36)	5 years
Secondary	Quality of life monitoring - 2	Quality of life estimated by validated questionnaires: International Prostatic Symptom Score (IPSS)	5 years