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NCT03205670

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

Status unknown EARLY_PHASE1 Last updated 17 February 2020
What this trial tests

EARLY_PHASE1 trial testing Urethroplasty with a tissue-engineered construct in Urethral Stricture in 6 participants. Status unknown.

Timeline
1 June 2017
Primary endpoint
1 June 2022
1 June 2022

Quick facts

Lead sponsorI.M. Sechenov First Moscow State Medical University
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date1 June 2017
Primary completion1 June 2022
Estimated completion1 June 2022
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 18 to 78, male only, with Urethral Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Urethral Stricture

Currently open trials in the same condition.

Other I.M. Sechenov First Moscow State Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03205670.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing