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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: Recruiting Phase 1 study of Urologic Diseases and Male Urogenital Diseases, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate of adverse events reported for each patient
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 |
What NCT03258658 shows while recruiting
NCT03258658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 120-participant average among 11 other Urologic Diseases trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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
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Where NCT03258658's enrollment target sits among peer trials
10 11th of 11 higher than 1 of 11 other Urologic Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urologic Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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