Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age21-75
SponsorWake Forest University Health Sciences
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be available for all follow-up visits.
Ability to speak English.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Engineered Urethral Construct
Biological/Vaccineurethral construct
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Autologous Engineered Urethral ConstructExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of product-related, biopsy procedure-related, and injection procedure-related adverse events
Rate of adverse events reported for each patient
Time frame
monitored through 36 months post treatmentSecondary outcomes
1
Effectiveness of urethral construct in repairing urethral stricture
Improvement in peak urinary flow rate defined as Qmax improvement from baseline
Time frame
monitored through 36 months post construct implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov