Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora (NCT03463239)
Phase 1 Pilot Study of Bioengineered Penile Tissue Constructs in Subjects With Irreversibly Damaged Penile Corpora
π©Ί Plain-English Summary (8th-Grade Level)
The primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.
Who can join: Review the eligibility criteria below.
Location: Wake Forest Institute for Regenerative Medicine β Winston-Salem, North Carolina
Age range: 18 Years to 60 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 (1 Sites)
- Wake Forest Institute for Regenerative Medicine 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
- Canadian Cohort of Convective Thermal Therapy Using RezΕ«m System in Benign Prostatic Hyperplasia (BPH). β Toronto, Ontario
- Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures β San Francisco, California
- 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.