Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03463239
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous tissue engineered corpora — BIOLOGICAL
    penile tissue construct

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous tissue engineered corpora
    All subjects enrolled will undergo a corpora cavernosum biopsy. Endothelial and smooth muscle cells will be isolated and expanded, then seeded onto a scaffold that will later be implanted into the subject.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: monitored through 36 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Institute for Regenerative MedicineWinston-SalemNorth Carolina27157
Mary-Clare Day, RN, BSN
[email protected]
336-713-1343
James Yoo, MD (SUB_INVESTIGATOR)

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By research site
Wake Forest Institute for Regenerative Medicine· Winston-Salem, NC

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