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NCT03463239 · ClinicalTrials.gov registry record · Phase 1
Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Not yet
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03463239: Clinical Trial Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03463239 is a Phase 1 study that has not yet begun recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03463239, a Phase 1 study, has not yet begun recruiting, sponsored by Wake Forest University Health Sciences.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
rate of adverse events reported for each patient
Interventions
- BIOLOGICAL Autologous tissue engineered corpora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-10 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
What is known before NCT03463239 opens enrollment
NCT03463239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Autologous tissue engineered corpora is the first listed.
NCT03463239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03463239 about?
NCT03463239 is a clinical study titled "Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora". 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 ...
What is the current status of trial NCT03463239?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-10. Estimated completion is 2030-12.
What interventions are being tested in trial NCT03463239?
The interventions under investigation include: Autologous tissue engineered corpora (BIOLOGICAL).
Who is sponsoring clinical trial NCT03463239?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03463239's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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