Clinical trial NCT03205670: Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Urethral Stricture
Keywords: Autologous Cells
Buccal Mucosa
Urethroplasty
Tissue-engineered Construct
Hybrid matrix
Collagen
Polylactoglycolide Fibers
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Serious adverse events
timeFrame: 4 weeks after surgery
measure: Serious adverse reactions
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Retrograde urethrography
timeFrame: 5 years
measure: Voiding cystourethrography
timeFrame: 5 years
measure: Pericatheter urethrography
timeFrame: 4 weeks after surgery
measure: Biopsy
timeFrame: 4 months after surgery
measure: Urodynamic changes via uroflowmetry - 1
timeFrame: 5 years
measure: Urodynamic changes via uroflowmetry - 2
timeFrame: 5 years
measure: Urodynamic changes via uroflowmetry - 3
timeFrame: 5 years
measure: Urodynamic changes via uroflowmetry - 4
timeFrame: 5 years
measure: Quality of life monitoring - 1
timeFrame: 5 years
measure: Quality of life monitoring - 2
timeFrame: 5 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: Sechenov First Moscow State Medical University
name: Denis Butnaru, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sechenov First Moscow State Medical University
name: Andrey Vinarov, Dr., Prof.
role: PRINCIPAL_INVESTIGATOR
References: