A Phase 2/3 interventional study of Monoclonal Antibody (Humanized Anti-CD52) and Tacrolimus in Amputation, Wounds and Injuries and Amputation, Traumatic, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment
Injuries to the genitalia are of concern to the military with emphasis 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 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, subsequent explantation or loss of the reconstruction.
The investigators propose this clinical trial to determine functional outcomes and quality of life 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 deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate 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 superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.
Specific Aims: 1) To assess the feasibility and function of penile allotransplantation in Wounded Warriors and civilians who have lost their penis due to battle or traumatic injury, using an immunomodulatory protocol to reduce immunosuppression; 2) To assess pre-to-post changes in QOL in patients who undergo penile allotransplantation.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's planned enrollment of 60 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Amputation, Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Donor Inclusion Criteria:
Recipient Inclusion Criteria:
Recipient and Donor Exclusion Criteria:
Donor Only Exclusion Criteria:
Recipient Only Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Monoclonal Antibody (Humanized Anti-CD52) · Drug: Tacrolimus · Procedure: Penile Allotransplantation
Allograft Survival
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
Time frame: Transplantation through end of study period (up to 5 years)
Quality of Life (QOL) as assessed by Brief Symptom Inventory
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.
Time frame: Transplantation through end of study period ( 5 years)
QOL as assessed by Affect Balance Scale (ABS)
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.
Time frame: Transplantation through end of study period (up to 5 years)
QOL as assessed by NEO Five-Factor Inventory Scale (NEO-FFI)
NEO-FFI is used to examine personality traits. Questions consists of 60 items. Items are scored from Strongly disagree to Strongly agreed
Time frame: Transplantation through end of study period (up to 5 years)
QOL as assessed by the International Index of Erectile Function (IIEF)
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.
Time frame: Transplantation through end of study period (up to 5 years)
Psychosexual Measures assessed by Self-Esteem and Relationship (SEAR) questionnaire
14 item questionnaire where responses are scored from 1-5. Response of 1 indicating almost never/never to 5 indicating almost always/always
Time frame: Transplantation through end of study period ( 5 years)
T0 asses Erection Hardness Score (EHS)
EHS rates the hardness of erection on a scale of one to four, with four being the maximal score.
Time frame: Transplantation through end of study period ( 5 years)
Modified Sexual Life Quality Questionnaire-Quality of Life (mSLQQ- QoL)
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.
Time frame: Transplantation through end of study period ( 5 years)
Psychological Measures by Satisfaction with Life Scale (SWLS)
SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates Strongly disagree to 7 indicating strongly agree.
Time frame: Transplantation through end of study period ( 5 years)
Brief Pain Inventory (Short Form) ) (BPISF)
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.
Time frame: Transplantation through end of study period ( 5 years)
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Studies of the drugs tested here: Antibodies, Monoclonal · Tacrolimus