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

NCT03258658 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this 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

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

Interventions

BIOLOGICAL

Autologous Engineered Urethral Construct

urethral construct

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • James Yoo, MD · Wake Forest Institute for Regenerative Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258658 on ClinicalTrials.gov