Grant Award Details
- The objective is to conduct a first in human clinical trial of a tissue engineered, autologous smc and urothelial cell progenitor seeded graft for long urethral strictures in men. Seven of ten total patients will be enrolled in California at UCSF.
Grant Application Details
- Phase I Treatment of Urethral Strictures in Humans
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.
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.
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
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.