UnknownEarly Phase 1

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

Russia6 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 78 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serious adverse events

Timeframe: 4 weeks after surgery

Serious adverse reactions

Timeframe: 4 weeks after surgery

Trial details

NCT IDNCT03205670

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

View on ClinicalTrials.gov More Urethral Stricture trials