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

Primary Purpose

Urethral Stricture

Status
Unknown status
Phase
Early Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Urethroplasty with a tissue-engineered construct
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture focused on measuring Autologous Cells, Buccal Mucosa, Urethroplasty, Tissue-engineered Construct, Hybrid matrix, Collagen, Polylactoglycolide Fibers

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Sechenov University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urethroplasty with a tissue-engineered construct

Arm 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.

Outcomes

Primary Outcome Measures

Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)

Secondary Outcome Measures

Retrograde urethrography
Influence of the surgery on the urethral lumen
Voiding cystourethrography
Full assessment of the urethral lumen after the surgery
Pericatheter urethrography
Assessment of absence or presence of contrast medium leakage outside the urethra
Biopsy
Control of anatomical urethral structure in the intervention place
Urodynamic changes via uroflowmetry - 1
Influence of the surgery on urinary flow rate: maximum flow rate
Urodynamic changes via uroflowmetry - 2
Influence of the surgery on urinary flow rate: average flow rate
Urodynamic changes via uroflowmetry - 3
Influence of the surgery on urinary flow rate: total volume voided
Urodynamic changes via uroflowmetry - 4
Influence of the surgery on urinary flow rate: maximum flow time
Quality of life monitoring - 1
Quality of life estimated by validated questionnaires: Short Form (SF-36)
Quality of life monitoring - 2
Quality of life estimated by validated questionnaires: International Prostatic Symptom Score (IPSS)

Full Information

First Posted
June 26, 2017
Last Updated
February 14, 2020
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03205670
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
Autologous Cells, Buccal Mucosa, Urethroplasty, Tissue-engineered Construct, Hybrid matrix, Collagen, Polylactoglycolide Fibers

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Butnaru, Dr.
Organizational Affiliation
Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey Vinarov, Dr., Prof.
Organizational Affiliation
Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sechenov University
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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