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Study identifier: NCT03258658 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Urologic Diseases · Male Urogenital Diseases · Urethral Stricture  ·  Sponsor: Wake Forest University Health Sciences

PhasePhase 1
Planned participants10
Who can joinMale, 21 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mary-Clare Day, RN, BSN  ·  336-713-1343  ·  Maryclare.Day@advocatehealth.org

Always discuss trial participation with your own doctor first.

Locations (2)

University of California San FranciscoSan Francisco, California, United StatesNot Yet Recruiting
Wake Forest Institute for Regenerative Medicine (WFIRM)Winston-Salem, North Carolina, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03258658