Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03258658 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
A Phase 1 study of Urologic Diseases and Male Urogenital Diseases, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT03258658 is a Phase 1 study of Urologic Diseases and Male Urogenital Diseases that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 120-participant average among 11 other Urologic Diseases trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03258658, a Phase 1 study of Urologic Diseases and Male Urogenital Diseases, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of urethral strictures.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Engineered Urethral Construct
Study Locations (2)
California
- University of California San Francisco - San Francisco
North Carolina
- Wake Forest Institute for Regenerative Medicine (WFIRM) - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-03 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03258658
The ClinicalTrials.gov registry entry for NCT03258658 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 11 other Urologic Diseases trials with a reported enrollment target (92% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Urologic Diseases appearing as the primary indexed condition, and to 1 intervention - of which Autologous Engineered Urethral Construct is the first listed.
NCT03258658 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03258658 about?
NCT03258658 is a clinical study titled "Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures". This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous uroth...
What is the current status of trial NCT03258658?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-03. Estimated completion is 2029-12.
What conditions does trial NCT03258658 study?
This clinical trial studies the following conditions: Urologic Diseases, Male Urogenital Diseases, Urethral Stricture, Urethral Injury.
What interventions are being tested in trial NCT03258658?
The interventions under investigation include: Autologous Engineered Urethral Construct (BIOLOGICAL).
Who is sponsoring clinical trial NCT03258658?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03258658 being conducted?
This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urologic Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
COMPLETED · Phase 1
-
Development of a New Canadian Endourology Group Stent Symptom Score
RECRUITING
-
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
RECRUITING · Phase 2
-
Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
RECRUITING · NA
-
Trial for Reliability of Urodynamics SysTem
RECRUITING · NA
-
Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.