NCT03258658

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures

A Phase 1 Pilot Safety and Feasibility Study of Autologous Engineered Urethral

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 Polyglycolic Acid (PGA) scaffolds to create autologous urethral constructs for the repair of urethral strictures. Male patients, aged 21-65 years old, seen in the Wake Forest Baptist Health urology clinic, referred to or self-referred to the study team, with recurrent urethral stricture, previously treated with dilation, internal urethrotomy, or urethroplasty, will be approached and offered consent to participate in in the trial. Up to 20 men may undergo screening procedures to identify 10 eligible subjects meeting all inclusion and exclusion criteria. All eligible subjects will undergo full thickness bladder tissue biopsies at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina to obtain UCs and SMCs, which will be cultured and expanded and then seeded on tubular PGA scaffolds. Approximately 6 weeks after biopsy, the subjects will return to undergo surgical removal of the stricture and implant of the urethral construct. Subjects will be followed through 36 months.

Conditions

• Urologic Diseases
• Male Urogenital Diseases
• Urethral Stricture
• Urethral Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Engineered Urethral Construct	urethral construct

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2017-08-23
• Last updated: 2025-08-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study