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Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463239
Recruitment Status : Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE February 18, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date December 22, 2022
Estimated Study Start Date  ICMJE March 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: monitored through 36 months post-treatment ]
rate of adverse events reported for each patient
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Number of participants with graft thrombosis or grant failures [ Time Frame: monitored through 36 months post-treatment ]
lack of graft thrombosis or graft failure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
Official Title  ICMJE Phase 1 Pilot Study of Bioengineered Penile Tissue Constructs in Subjects With Irreversibly Damaged Penile Corpora
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.
Detailed Description

Damage to penile tissue due to infection, inflammation or trauma often leads to structural deformity that may result in loss of sexual function that can profoundly affect quality of life. Traumatic injuries in civilians and battlefield related injuries in soldiers often require reconstructive procedures to restore the anatomy and functionality of the penis. However, these procedures are often limited by poor availability of functionally intact penile tissue. Various penile reconstructive procedures, such as penile prostheses and autograft implantation have been attempted. While cosmetic appearance may be improved, restoration of spontaneous and natural erectile function is usually not achieved. This is often due to critical defect of the corpora cavernosa, which are responsible for erectile function. Recently, the concept of a tissue engineering-based therapy has been proposed for reconstructing damaged penile corporal tissue.

The primary objective of this Armed Forces Institute for Regeneration Medicine (AFIRM II) sponsored clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. The proposed study design is a prospective non-randomized and uncontrolled, multi-center investigation. Autologous endothelial and smooth muscle cells obtained from enrolled participants' 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.

A total of ten male patients, referred for the treatment of damages of albuginea and/or corpora cavernosum without concurrent urethral injury will be recruited for this study. The estimated duration of the study for each subject following treatment is 36 months. The study team anticipates a duration of approximately 48 to 60 months to complete all enrollment and follow up. Enrolled participants will undergo a corporal tissue biopsy as an out-patient surgical procedure. Autologous corporal smooth muscle cells and corporal endothelial cells will be isolated and then seeded on cadaveric decellularized corporal bodies. Approximately 3-4 weeks later, the engineered construct including corporal tissue with attached tunica will be transplanted into the surgically prepared site of penile injury. Participants will be followed through 36 months post-implantation to monitor for safety.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urologic Diseases
  • Male Urogenital Diseases
  • Penile Diseases
  • Corpus Callosum Malformation
  • Corpora Cavernosa; Inflammation
  • Trauma Injury
Intervention  ICMJE Biological: Autologous tissue engineered corpora
penile tissue construct
Study Arms  ICMJE 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.
Intervention: Biological: Autologous tissue engineered corpora
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males aged 18-60 years.
  2. 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.
  3. Stable abnormalities - at least 6 months with no pain or changes in deformity.
  4. At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment
  5. Deformities less than 5 cm in length.
  6. Written informed consent obtained prior to participation in the study.
  7. Patients must be available for all follow up visits.
  8. Ability to speak English.

Exclusion Criteria:

  1. Presence of untreated or incompletely treated urinary tract infection at the time of biopsy.
  2. Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
  3. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease.
  4. ALT or AST value >1.5 times the upper limit of normal.
  5. Albumin < 3.0 g/dL.
  6. Serum direct bilirubin >0.3 mg/dL OR total bilirubin > 1.4 mg/dL
  7. BM I>40 kg/m2
  8. Uncontrolled diabetes with HbA1C>9%. (Subjects with controlled diabetes must be under care of diabetologist with treatment goals consistent with ADA criteria).
  9. Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure.
  10. Unstable pulmonary disorders within the past 6 months including dyspnea on exertion, chronic productive cough, pneumonia, hemoptysis, asthma requiring nebulized therapy.
  11. 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.
  12. Known to be colonization with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
  13. Immunocompromised subjects or subjects receiving immunosuppressive agents.
  14. Any history of alcohol and/or drug abuse.
  15. 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.
  16. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study.
  17. Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.
  18. Inability to participate in all necessary study activities due to physical or mental limitations.
  19. Inability or unwillingness to return for all required follow-up visits, for instance life expectancy < 1 year, or subject who knows they will be moving out of the country and unable to return for follow-up visits.
  20. Inability or unwillingness to sign informed consent.
  21. Patients requiring concomitant use of or treatment with immunosuppressive agents
  22. Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary-Clare Day, RN, BSN 336-713-1343 mday@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03463239
Other Study ID Numbers  ICMJE IRB00046975
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Wake Forest University Health Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Wake Forest University Health Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Ryan P Terlecki, MD Associate Professor
PRS Account Wake Forest University Health Sciences
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP