Urethral StrictureEarly Phase 1NCT03205670
Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers
A Early Phase 1 study testing Urethroplasty with a tissue-engineered construct in people with Urethral Stricture, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Urethroplasty with a tissue-engineered construct
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2017to 1 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Urethroplasty with a tissue-engineered construct
- Keywords
- Autologous Cells, Buccal Mucosa, Urethroplasty, Tissue-engineered Construct, Hybrid matrix, Collagen, Polylactoglycolide Fibers
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethroplasty with a tissue-engineered constructProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Urethroplasty with a tissue-engineered construct | Experimental | 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. Receives: Procedure: Urethroplasty with a tissue-engineered construct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Measured: 4 weeks after surgery
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Measured: 4 weeks after surgery
Secondary outcomes (10)
Retrograde urethrography
Influence of the surgery on the urethral lumen
Measured: 5 years
Voiding cystourethrography
Full assessment of the urethral lumen after the surgery
Measured: 5 years
Pericatheter urethrography
Assessment of absence or presence of contrast medium leakage outside the urethra
Measured: 4 weeks after surgery
Biopsy
Control of anatomical urethral structure in the intervention place
Measured: 4 months after surgery
Urodynamic changes via uroflowmetry - 1
Influence of the surgery on urinary flow rate: maximum flow rate
Measured: 5 years
Urodynamic changes via uroflowmetry - 2
Influence of the surgery on urinary flow rate: average flow rate
Measured: 5 years
Urodynamic changes via uroflowmetry - 3
Influence of the surgery on urinary flow rate: total volume voided
Measured: 5 years
Urodynamic changes via uroflowmetry - 4
Influence of the surgery on urinary flow rate: maximum flow time
Measured: 5 years
Quality of life monitoring - 1
Quality of life estimated by validated questionnaires: Short Form (SF-36)
Measured: 5 years
Quality of life monitoring - 2
Quality of life estimated by validated questionnaires: International Prostatic Symptom Score (IPSS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Butnaru, MD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Denis Butnaru, Dr., Principal investigator, Sechenov First Moscow State Medical UniversityAndrey Vinarov, Dr., Prof., Principal investigator, Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205670
- Sponsor's protocol ID
- SU-IRM-2017-0001
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03205670
- Acronym / sponsor ID
- SU-IRM-2017-0001
- Conditions
- Urethral Stricture
- Keywords
- Autologous Cells, Buccal Mucosa, Urethroplasty, Tissue-engineered Construct, Hybrid matrix, Collagen, Polylactoglycolide Fibers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urethroplasty with a tissue-engineered construct | Experimental | Procedure: Urethroplasty with a tissue-engineered constructThe 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urethroplasty with a tissue-engineered constructThe investigators will perform urethroplasty with the tissue-engineered construct - epithelial cells isolated from patient's buccal mucosa and seeded on a collagen-polylactoglycolide matrix. | Procedure or surgery | Urethroplasty with a tissue-engineered construct |
Primary outcome
Serious adverse events
Time frame: 4 weeks after surgery
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Time frame: 4 weeks after surgery
Frequency, type and severity of serious adverse reactions (SAR)
10 secondary outcomes
Retrograde urethrography
Time frame: 5 years
Voiding cystourethrography
Time frame: 5 years
Pericatheter urethrography
Time frame: 4 weeks after surgery
Biopsy
Time frame: 4 months after surgery
Urodynamic changes via uroflowmetry - 1
Time frame: 5 years
Urodynamic changes via uroflowmetry - 2
Time frame: 5 years
Urodynamic changes via uroflowmetry - 3
Time frame: 5 years
Urodynamic changes via uroflowmetry - 4
Time frame: 5 years
Quality of life monitoring - 1
Time frame: 5 years
Quality of life monitoring - 2
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Urethral Stricture
Recruiting
Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.
Urethral Stricture
Active, not recruiting
Outcomes of Double-face Augmentation Urethroplasty
Urethral Stricture, Anterior, Urethral Stricture Disease
Active, not recruitingPhase 4
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Urethral Stricture
Active, not recruiting
Early vs Late Urinary Catheter Removal After Renal Transplantation
Kidney Transplant; Complications, Kidney Transplant Infection
Active, not recruitingPhase 2
LishitonglinUS-01 Trial
Urethra Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Butnaru, Dr. principal investigator
Sechenov First Moscow State Medical University
Andrey Vinarov, Dr., Prof. principal investigator
Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Urethroplasty with a tissue-engineered construct in people with Urethral Stricture, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: 4 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.