Human Penile Allotransplantation
|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: NCT02395497|
Recruitment Status : Recruiting
First Posted : March 23, 2015
Last Update Posted : April 21, 2020
Injuries to the external genitalia are of great concern to the military with emphasis being placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue (i.e., the forearm or thigh) due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, and subsequent explantation or loss of the reconstruction.
For these reasons, the investigators propose the current clinical trial to determine functional outcomes and quality of life (QOL) for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary (GU) deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to implement this study. The investigators anticipate that penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.
Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate equivalent or superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.
|Condition or disease||Intervention/treatment||Phase|
|Amputation Wounds and Injuries Amputation, Traumatic Urologic Surgical Procedures, Male Amputation, Traumatic/Surgery Penis/Transplantation Penis/Surgery Penis/Injuries||Procedure: Penile Transplant Biological: Monoclonal Antibody (Humanized Anti-CD52) Drug: Tacrolimus||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Human Penile Allotransplantation|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Experimental: Treatment: Transplantation
Penile transplantation with an immunomodulatory protocol consisting of 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)
- Allograft Survival [ Time Frame: Transplantation through end of study period (up to 5 years) ]use an immunomodulatory protocol to reduce immunosuppression. Post-operative allograft survival will be assessed by various clinical measures including: physical assessments, imaging assessments (ultrasound, CT angiography, magnetic resonance (MR) Neurography and MRI) immune monitoring (screen patient sera for donor specific antibodies), hematologic and metabolic tests, viral tests, chimerism tests, and skin biopsies
- Quality of Life (QOL) as assessed by Brief Symptom Inventory [ Time Frame: Transplantation through end of study period ( 5 years) ]Brief Symptom Inventory questionnaire evaluates psychological distress and psychiatric disorders. It consists of 53-item self-report inventory in which participants rate the extent to which they have been bothered. 5-point rating scale, 0 indicating not at all bothered to 4 extremely bothered.
- QOL as assessed by Affect Balance Scale (ABS) [ Time Frame: Transplantation through end of study period (up to 5 years) ]ABS is a 10-item questionnaire that assess positive and negative affect as indicators of life satisfaction and/or well-being. Score range from 0-4. 0 indicating the feeling never affected to 4, where the feeling is affected always.
- QOL as assessed by NEO Five-Factor Inventory Scale (NEO-FFI) [ Time Frame: Transplantation through end of study period (up to 5 years) ]NEO-FFI is used to examine personality traits. Questions consists of 60 items. Items are scored from Strongly disagree to Strongly agreed
- QOL as assessed by the International Index of Erectile Function (IIEF) [ Time Frame: Transplantation through end of study period (up to 5 years) ]A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
- Psychosexual Measures assessed by Self-Esteem and Relationship (SEAR) questionnaire [ Time Frame: Transplantation through end of study period ( 5 years) ]14 item questionnaire where responses are scored from 1-5. Response of 1 indicating almost never/never to 5 indicating almost always/always
- T0 asses Erection Hardness Score (EHS) [ Time Frame: Transplantation through end of study period ( 5 years) ]EHS rates the hardness of erection on a scale of one to four, with four being the maximal score.
- Modified Sexual Life Quality Questionnaire-Quality of Life (mSLQQ- QoL) [ Time Frame: Transplantation through end of study period ( 5 years) ]Used to validate as a tool for evaluating sexual QoL. mSLQQ is measured from score of 0 to 8. 0 indicates a low score compare to 8, indicating high. A score of 4 indicates, nothing has been changed.
- Psychological Measures by Satisfaction with Life Scale (SWLS) [ Time Frame: Transplantation through end of study period ( 5 years) ]SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates Strongly disagree to 7 indicating strongly agree.
- Brief Pain Inventory (Short Form) ) (BPISF) [ Time Frame: Transplantation through end of study period ( 5 years) ]BPISF assesses the severity of pain and its impact on functioning. It is scored from 0 to 10, 0 indicating no pain, does not interfere to 10 indicating pain as bad as you can imagine, completely interferes.
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): NCT02395497
|Contact: Jane Littleton, CRNP, MSNemail@example.com|
|Contact: Vidhi Javia, BSfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Carisa Cooney, MPH,CCRP 443-287-4629 email@example.com|
|Contact: Vidhi Javia, BS 443-287-7848 firstname.lastname@example.org|
|Principal Investigator: Richard Redett, MD|
|Sub-Investigator: Damon Cooney, MD,PHD|
|Sub-Investigator: Gerald Brandacher, MD|
|Sub-Investigator: Arthur Burnett, MD|
|Sub-Investigator: W. P. Andrew Lee, MD|
|Principal Investigator:||Richard Redett, MD||Johns Hopkins University|