Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
United States10 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range18 Years ā 60 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Males aged 18-60 years.
ā. Acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis. These abnormalities will be diagnosed by clinical examination, and/or ultrasound, and/or computerized tomography.
ā. Stable abnormalities - at least 6 months with no pain or changes in deformity.
ā. At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment
ā. Deformities less than 5 cm in length.
ā. Written informed consent obtained prior to participation in the study.
ā. Patients must be available for all follow up visits.
ā. Ability to speak English.
Exclusion criteria
ā. Presence of untreated or incompletely treated urinary tract infection at the time of biopsy.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: monitored through 36 months post-treatment
. Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
ā. Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.
ā. ALT or AST value \>1.5 times the upper limit of normal.
ā. Albumin \< 3.0 g/dL.
ā. Serum direct bilirubin \>0.3 mg/dL OR total bilirubin \> 1.4 mg/dL
ā. BM I\>40 kg/m2
ā. Uncontrolled diabetes with HbA1C\>9%. (Subjects with controlled diabetes must be under care of diabetologist with treatment goals consistent with ADA criteria).