Engineered Urethral Tissue for Urethral Stricture
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive agents or certain treatments for urological conditions, you may not be eligible to participate.
What data supports the effectiveness of the treatment Autologous Engineered Urethral Construct for urethral stricture?
Research shows that using a patient's own cells to create engineered urethral tissue can help manage long and complex urethral strictures, potentially preventing them from coming back. This approach has been tested in patients needing urethral reconstruction and has shown promise in repairing urethral defects.12345
Is the engineered urethral tissue treatment safe for humans?
How is the treatment Autologous Engineered Urethral Construct different from other treatments for urethral stricture?
This treatment uses the patient's own cells to create a new urethral tissue, which can help prevent the recurrence of strictures (narrowing of the urethra) and offers a more natural and potentially longer-lasting solution compared to traditional surgical methods that often involve grafts or flaps.12378
Research Team
James Yoo, MD
Principal Investigator
Wake Forest Institute for Regenerative Medicine
Eligibility Criteria
Adult males with urethral strictures who have had at least one failed conservative treatment, a stricture length of 10-60 mm, and can't pass a cystoscope. Excluded are those with certain skin conditions, bleeding or coagulation disorders, low albumin levels, neurological issues like MS or Parkinson's disease, untreated UTIs, systemic diseases like HIV or diabetes, recent other trial participation or investigational drug use within 30 days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Biopsy and Cell Expansion
Participants undergo a full-thickness bladder biopsy to obtain urothelial and smooth muscle cells, which are then cultured and expanded over 4-6 weeks.
Surgical Implantation
Participants undergo surgical removal of the urethral stricture and implantation of the autologous engineered urethral construct.
Follow-up
Participants are monitored for safety and effectiveness of the urethral construct, including improvement in peak urinary flow rate and adverse events.
Treatment Details
Interventions
- Autologous Engineered Urethral Construct
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
United States Department of Defense
Collaborator