Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
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|ClinicalTrials.gov Identifier: NCT03463239|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urologic Diseases Male Urogenital Diseases Penile Diseases Corpus Callosum Malformation Corpora Cavernosa; Inflammation Trauma Injury||Biological: Autologous tissue engineered corpora||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Pilot Study of Bioengineered Penile Tissue Constructs in Subjects With Irreversibly Damaged Penile Corpora|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2023|
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.
Biological: Autologous tissue engineered corpora
penile tissue construct
- 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
- Number of participants with graft thrombosis or grant failures [ Time Frame: monitored through 36 months post-treatment ]lack of graft thrombosis or graft failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463239
|Contact: Mary-Clare Day, RN, BSNfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Institute for Regenerative Medicine||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Mary-Clare Day, RN, BSN 336-713-1343 email@example.com|
|Sub-Investigator: James Yoo, MD|
|Principal Investigator:||Ryan P Terlecki, MD||Associate Professor|