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Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora

NCT03463239 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • Urologic Diseases
  • Male Urogenital Diseases
  • Penile Diseases
  • Corpus Callosum Malformation
  • Corpora Cavernosa; Inflammation
  • Trauma Injury

Interventions

BIOLOGICAL

Autologous tissue engineered corpora

penile tissue construct

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ryan P Terlecki, MD · Associate Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463239 on ClinicalTrials.gov