Actively Recruiting
Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
Led by Wake Forest University Health Sciences · Updated on 2025-08-27
10
Participants Needed
2
Research Sites
195 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 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
Official 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 between 21 and 65 years
- History of urethral stricture 15 to 60 mm in length as shown by urethrography
- At least one strictured segment through which a 16 Fr flexible cystoscope cannot be passed atraumatically
- Availability for all follow-up visits
- Ability to speak English
You will not qualify if you...
- Strictures of the meatus or prostatic urethra
- Strictures linked to or suspected to be urethral carcinoma or due to pelvic distraction injuries
- Strictures shorter than 10 mm or longer than 60 mm
- Untreated urinary tract infection
- History or presence of lichen sclerosis et atrophicus
- Uncontrolled bleeding disorders or low platelet count below 50,000
- Any urological condition likely requiring additional urethral instrumentation during the study period
- Serum creatinine over 2.0 mg/dl or progressive kidney disease
- Abnormal urologic conditions like vesicoureteral reflux, bladder stones, bladder tumors, or renal impairment
- Elevated liver enzymes or low albumin levels
- Uncontrolled diabetes or unstable heart/lung conditions
- Active or recent tuberculosis without completed treatment
- Colonization with MRSA, VRE, or gentamicin-resistant organisms
- Immunocompromised status or use of immunosuppressive agents beyond allowed doses
- History of alcohol or drug abuse
- Current smoker
- Positive results or history of HIV, Hepatitis B or C, or other infectious diseases
- Systemic conditions that may risk patient safety
- Participation in other clinical trials within 30 days before enrollment
- Current illnesses that could affect study results such as bladder atonia or neurogenic bladder
- Physical or mental limitations preventing study participation
- Inability or unwillingness to return for follow-up visits or sign consent
- Use of immunosuppressive treatments
- Neurological disorders such as multiple sclerosis or Parkinson's disease
AI-Screening
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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
CONTACT
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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