Actively Recruiting
A Phase 1 Pilot Safety and Feasibility Study of Autologous Engineered Urethral Constructs for Treating Urethral Strictures in Adult Males
Led by Wake Forest University Health Sciences · Updated on 2026-06-04
10
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the safety and effectiveness of using autologous engineered urethral constructs for treating urethral strictures in adult males. It is a Phase I, prospective, non-randomized, and uncontrolled single-center study enrolling male patients aged 21 to 65 years with recurrent urethral strictures who have previously undergone treatments such as dilation, urethrotomy, or urethroplasty. Participants will have full-thickness bladder biopsies to collect urothelial and smooth muscle cells, which will be expanded in the lab and seeded onto tubular polyglycolic acid scaffolds to create personalized urethral constructs. Around six weeks after biopsy, participants will undergo surgery to remove the urethral stricture and implant the engineered construct. All subjects will be followed for safety and efficacy over a 36-month period. During the study, participants will have follow-up visits to monitor for any adverse events related to the product, biopsy, or injection procedures. Effectiveness of the urethral construct in repairing the stricture will be assessed throughout the 36 months. The study involves surgical procedures, cell culture, and long-term monitoring to evaluate the treatment approach comprehensively.
CONDITIONS
Brief Title
Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 21 to 65 years
- History of at least one urethral stricture 15-60 mm in length as confirmed by urethrography
- Stricture contains at least one segment through which a 16 Fr flexible cystoscope cannot be passed without trauma
- Available and willing to attend all follow-up visits
- Ability to speak English
You will not qualify if you...
- Strictures of the meatus or prostatic urethra or associated with urethral cancer or pelvic distraction injuries
- Strictures less than 10 mm or greater than 60 mm in length
- Untreated urinary tract infection
- History or presence of lichen sclerosis et atrophicus
- Uncontrolled bleeding disorders or low platelet count
- Urological conditions requiring additional instrumentation during study period such as untreated benign prostatic hyperplasia, active prostate cancer, bladder cancer, or recurrent urinary stones
- Coagulation disorders or anticoagulation therapy at enrollment
- Serum creatinine over 2.0 mg/dl or progressive kidney disease
- Abnormal urologic conditions including vesicoureteral reflux, bladder stones, tumors, or renal impairment
- Liver enzyme levels more than 3 times normal or low albumin
- Uncontrolled diabetes or unstable heart/lung disorders
- Active tuberculosis requiring treatment within past 3 years or positive untreated PPD test
- Colonization with MRSA, VRE, or gentamicin-resistant organisms
- Immunocompromised status or use of immunosuppressive drugs above permitted levels
- History of alcohol or drug abuse
- Current smoker
- Positive history or test for HIV, Hepatitis B or C, or any infectious or sexually transmitted disease
- Systemic conditions that may jeopardize safety
- Participation in other clinical trials within 30 days prior
- Any illness that might affect study results like bladder atonia or spinal cord injury
- Investigator discretion if participation is not in subject's best interest
- Physical or mental limitations preventing study participation
- Inability or unwillingness to attend all follow-up visits or sign consent
- Use of immunosuppressive agents during study
- Neurological disorders such as multiple sclerosis or Parkinson's disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks between biopsy and surgery
Participants undergo a full-thickness bladder biopsy to collect cells that are cultured and expanded to create an autologous engineered urethral construct. Approximately 6 weeks later, participants have surgery to remove the stricture and implant the engineered urethral construct.
2 surgical visits (outpatient biopsy and implant surgery)
Duration - Up to 36 months
Participants are followed for safety and efficacy monitoring after the implant surgery.
Multiple follow-up visits over 36 months
Trial Site Locations
Total: 2 locations
1
University of California San Francisco
San Francisco, California, United States, 94110
Not Yet Recruiting
2
Wake Forest Institute for Regenerative Medicine (WFIRM)
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
M
Mary-Clare Day, RN, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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