Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures (NCT03258658)
A Phase 1 Pilot Safety and Feasibility Study of Autologous Engineered Urethral
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco β San Francisco, California
Age range: 21 Years to 75 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (2 Sites)
- University of California San Francisco β San Francisco, California
- Wake Forest Institute for Regenerative Medicine (WFIRM) β Winston-Salem, North Carolina
π Contact the Study Coordinator
Phone: (336) 713-1343
Email: Maryclare.Day@advocatehealth.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urologic Diseases
- Trial for Reliability of Urodynamics SysTem β Murrieta, California
- Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora β Winston-Salem, North Carolina
- Canadian Cohort of Convective Thermal Therapy Using RezΕ«m System in Benign Prostatic Hyperplasia (BPH). β Toronto, Ontario
- Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms. β Indianapolis, Indiana
- Aquablation in Benign Prostatic Hyperplasia in Canada β Toronto, Ontario
Explore by condition: All Urologic Diseases clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.