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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463239
The ClinicalTrials.gov registry entry for NCT03463239 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Autologous tissue engineered corpora is the first listed.
NCT03463239 reports 0 study locations.
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.
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