Phase I Treatment of Urethral Strictures in Humans

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Grant Award Details

Grant Number:
Human Stem Cell Use:
Award Value:

Grant Application Details

Application Title:

Phase I Treatment of Urethral Strictures in Humans

Public Abstract:
Therapeutic Candidate or Device

An engineered urethral segment comprised of autologous urothelial, smooth muscle cells, and progenitor cells within a tubular scaffold.


Autologous engineered urethral constructs are for the replacement of urethral strictures that are too long for treatment by conventional methods.

Therapeutic Mechanism

The autologous engineered urethras are intended to replace the entire strictured region with a cellularized tubular scaffold. The engineered urethra
contains a progenitor cell population that supports tissue self-renewal while the construct remodels and integrates with adjacent tissue. The engineered
product eventually develops a cellular microarchitecture that is indistinguishable from native urethra; completely restoring normal urinary function for at
least a decade.

Unmet Medical Need

Current treatment options for short urethral strictures often fail in the long-term when applied to long segment strictures. Autologous engineered urethras
provide a long-term cure for long segment strictures and completely restores normal urinary function.

Project Objective

Complete Phase 1 Trial; apply for a Phase 2 trial.

Major Proposed Activities

  • Submit CIRM application to achieve funding for Phase 1 Clinical Trial and submit an IND Amendment to add site in California
  • Manufacture engineered urethral constructs using autologous urothelial, smooth muscle, and progenitor cells
  • Complete Phase 1 Clinical Trial and analyze patient outcomes
Statement of Benefit to California:
There are as many as 100K males in the state of California with urethral stricture. The cost to treat these patients approaches $20M annually. Almost 200,000 California citizens are in the US military, and at increased risk for traumatic urethral injury. The proposed treatment would provide a permanent cure for patients, reduce long-term costs associated with failed treatments, create jobs associated with biomanufacturing the constructs, and restore affected individuals quality of life.