Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora

NCT03463239 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB00046975
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Autologous tissue engineered corpora

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  rate of adverse events reported for each patient

  monitored through 36 months post-treatment

Secondary Outcomes (1)

• Number of participants with graft thrombosis or grant failures

  monitored through 36 months post-treatment

Study Arms (1)

Autologous tissue engineered corpora

EXPERIMENTAL

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.

Biological: Autologous tissue engineered corpora

Interventions

Autologous tissue engineered corpora BIOLOGICAL

penile tissue construct

Autologous tissue engineered corpora

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged 18-60 years.
• 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.
• Stable abnormalities - at least 6 months with no pain or changes in deformity.
• At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment
• Deformities less than 5 cm in length.
• Written informed consent obtained prior to participation in the study.
• Patients must be available for all follow up visits.
• Ability to speak English.

You may not qualify if:

• Presence of untreated or incompletely treated urinary tract infection at the time of biopsy.
• Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
• Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.
• ALT or AST value \>1.5 times the upper limit of normal.
• Albumin \< 3.0 g/dL.
• Serum direct bilirubin \>0.3 mg/dL OR total bilirubin \> 1.4 mg/dL
• BM I\>40 kg/m2
• Uncontrolled diabetes with HbA1C\>9%. (Subjects with controlled diabetes must be under care of diabetologist with treatment goals consistent with ADA criteria).
• Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure.
• Unstable pulmonary disorders within the past 6 months including dyspnea on exertion, chronic productive cough, pneumonia, hemoptysis, asthma requiring nebulized therapy.
• Active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
• Known to be colonization with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
• Immunocompromised subjects or subjects receiving immunosuppressive agents.
• Any history of alcohol and/or drug abuse.
• Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV). Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• United States Department of Defense: collaborator

Study Sites (1)

Wake Forest Institute for Regenerative Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Urologic Diseases; Male Urogenital Diseases; Penile Diseases; Agenesis of Corpus Callosum; Inflammation; Accidental Injuries

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wounds and Injuries

Study Officials

• Ryan P Terlecki, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343; Maryclare.Day@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: March 13, 2018
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)