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Autologous Engineered Urethral Construct · 1 trial · 4 indications
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| Arm | Type | Description |
|---|---|---|
| Autologous Engineered Urethral Construct | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Autologous Engineered Urethral Construct | BIOLOGICAL | urethral construct |
Inclusion Criteria: * Stricture of the urethra meeting the following criteria: a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed. * Patients must be av...
Autologous Engineered Urethral Construct is an investigational cell therapy being developed for the treatment of urethral strictures and urethral injury in male patients with urologic diseases. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Autologous Engineered Urethral Construct is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The therapy is currently in Phase 1 clinical trials.
Autologous Engineered Urethral Construct is in Phase 1 clinical development. It is an investigational therapy that has not yet been approved by the FDA. A Phase 1 clinical trial is currently recruiting participants to evaluate its safety and feasibility.
Autologous Engineered Urethral Construct is being studied in a Phase 1 clinical trial registered as NCT03258658. This trial is titled 'Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures' and is recruiting male patients aged 21 years and older in the United States.
Autologous Engineered Urethral Construct is a monoclonal antibody-based therapy. It is designed to treat urethral strictures by using a patient's own cells to construct a tissue graft that can repair or replace damaged urethral tissue, potentially restoring normal urinary function.