Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma
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|ClinicalTrials.gov Identifier: NCT03240822|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urologic Injuries Genital Diseases, Male Amputation||Procedure: Penile Transplant Biological: Monoclonal Antibody (Humanized Anti-CD52) Drug: Tacrolimus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects receive transplant and immunosuppression therapy|
|Masking:||None (Open Label)|
|Official Title:||Vascularized Composite Allotransplantation (VCA) for Devastating Penile and Concomitant Genital Trauma|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2025|
Experimental: Penile Allotransplant and Immunosuppression Treatment
Penile transplantation with monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.
Procedure: Penile Transplant
Biological: Monoclonal Antibody (Humanized Anti-CD52)
- Need for Immunosuppressive drug therapy [ Time Frame: 6 months ]The amount of immunosuppressive drug therapy will be recorded.
- erectile function [ Time Frame: 6 months ]This will be assessed following intracorporal injection of vaso-active agents, such as prostaglandin, phentolamine, papaverine, or some mixture of these drugs (i.e. Trimix). and through high-resolution duplex Doppler ultrasonography
- Assessment of sensory return and sensory thresholds [ Time Frame: 6 months ]This will be accomplished by penile biothesiometry
- Determination of hemodynamic status [ Time Frame: 6 months ]Dynamic infusion pharmaco-cavernosometry and cavernosography will be utilized to better understand these changes
- The Reintegration to Normal Living (RNL) Index [ Time Frame: 6 months ]The RNL is an 11-item questionnaire that asks how a person manages activities, roles, and relationships on a day-to-day basis.
- The Situational Inventory of Body-Image Dysphoria (SIBID) [ Time Frame: 6 months ]The SIBID is a multidimensional body-image survey assessment of people's negative body-image emotions in everyday situations and physical experiences.
- The Function and Body Image Survey [ Time Frame: 6 months ]This survey consists of six open-ended questions regarding personal thoughts, opinions, and experiences about the transplant, and the individual's current functional abilities.
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): NCT03240822
|Contact: Mary-Clare Day, RN BSN||(336) firstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest School of Medicine||Recruiting|
|Winston-Salem, North Carolina, United States, 27104|
|Contact: Mary-Clare Day, RN BSN 336-713-1343 Mday@wakehealth.edu|
|Principal Investigator:||Anthony Atala, MD||Professor|