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

NCT03258658 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB0004362440010001209
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• Incidence of product-related, biopsy procedure-related, and injection procedure-related adverse events

  Rate of adverse events reported for each patient

  monitored through 36 months post treatment

Secondary Outcomes (1)

• Effectiveness of urethral construct in repairing urethral stricture

  monitored through 36 months post construct implant

Study Arms (1)

Autologous Engineered Urethral Construct

EXPERIMENTAL

All subjects enrolled will undergo a full-thickness bladder biopsy as an out-patient surgical procedure. Urothelial and Smooth Muscle Cells recovered from the biopsy will be isolated and expanded over the next 4-6 weeks, and then seeded onto a tubular scaffold to create the autologous engineered urethral construct. Subjects will undergo a second surgical procedure to excise the urethral stricture and implant the urethral construct. All subjects will be followed for 3 years for safety and efficacy.

Biological: Autologous Engineered Urethral Construct

Interventions

Autologous Engineered Urethral Construct BIOLOGICAL

urethral construct

Autologous Engineered Urethral Construct

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stricture of the urethra meeting the following criteria:
• a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed.
• Patients must be available for all follow-up visits.
• Ability to speak English.

You may not qualify if:

• Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures \<10 mm or \>60 mm, as determined by urethrography, and criteria for bulbar urethral strictures excluding those with strictures \<20 mm and \>60 mm, as described by urethrography.
• Presence of untreated urinary tract infection.
• Presence or prior history of lichen sclerosis et atrophicus (previously termed 'balanitis xerotica obliterans').
• Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
• Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment).
• Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.
• Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment.
• Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal.
• Subjects with an albumin value \<3.0 g/dL.
• Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders.
• Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
• Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
• Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \[≤0.25 mg/kg prednisone or equivalent per day\] are permitted).
• Any history of alcohol and/or drug abuse.
• Current smoker.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (2)

University of California San Francisco

San Francisco, California, 94110, United States

NOT YET RECRUITING

Wake Forest Institute for Regenerative Medicine (WFIRM)

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Urologic Diseases; Male Urogenital Diseases; Urethral Stricture

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urethral Obstruction; Urethral Diseases

Study Officials

• James Yoo, MD

  Wake Forest Institute for Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343; mday@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 23, 2017
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)