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

Part of paid clinical trials in San Francisco, California.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03258658
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Engineered Urethral Construct — BIOLOGICAL
    urethral construct

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous Engineered Urethral Construct
    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.

Primary Outcome Measure

Incidence of product-related, biopsy procedure-related, and injection procedure-related adverse events [ Time Frame: monitored through 36 months post treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94110
Natalie Rios
[email protected]
415-723-1456
Benjamin Breyer, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Institute for Regenerative Medicine (WFIRM)Winston-SalemNorth Carolina27157
Mary-Clare Day, RN, BSN
[email protected]
336-713-1343
Ryan Terlecki, MD (PRINCIPAL_INVESTIGATOR)
James Yoo, MD (SUB_INVESTIGATOR)

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By research site
University of California San Francisco· San Francisco, CAWake Forest Institute for Regenerative Medicine (WFIRM)· Winston-Salem, NC

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