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AmputationPhase 2/3NCT02395497

Human Penile Allotransplantation

A Phase 2/3 study testing Monoclonal Antibody (Humanized Anti-CD52), Tacrolimus and Penile Allotransplantation in people with Amputation and Wounds and Injuries, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 69 years, men only
What is being tested?
Monoclonal Antibody (Humanized Anti-CD52), Tacrolimus and Penile Allotransplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jun 2014to Jun 2039
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Donor Inclusion Criteria:

  • Males aged 16 - 65 years.
  • Brain dead meeting the criteria for Determination of Death.
  • Family consent for penile graft donation.
  • Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).
  • Same blood type as recipient.
  • Negative lymphocytotoxic crossmatch.
  • Accurately matched for skin tone

Recipient Inclusion Criteria:

  • Males of any race, color or ethnicity; aged 18-69 years.
  • Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.
  • Penectomy secondary to penile cancer
  • Penile Cancer Survivors > 5 years
  • Micropenis associated with congenital/birth defect and severely ambiguous male genitalia
  • Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.
  • Completes the protocol informed consent form(s).
  • No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).
  • No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
  • Negative for malignancy for past 5 years.
  • Negative for HIV at transplant.
  • Negative crossmatch with donor.
  • Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.
  • USA citizen or equivalent.
  • Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.

Recipient and Donor Exclusion Criteria:

  • Untreated sepsis.
  • HIV (active or seropositive).
  • Active tuberculosis.
  • Active Hepatitis B infection.
  • Hepatitis C.
  • Viral encephalitis.
  • Toxoplasmosis.
  • Malignancy (within past 5 years).
  • Current/recent (within 3 months of donation/screening consent) IV drug abuse.
  • Paralysis of ischemic or traumatic origin.
  • Inherited peripheral neuropathy.
  • Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.
  • Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).
  • Mixed connective tissue disease.
  • Severe deforming rheumatoid or osteoarthritis in the limb.

Donor Only Exclusion Criteria:

  • Evidence of active herpes simplex virus-2 (HSV-2) infection.
  • Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.

Recipient Only Exclusion Criteria:

  • Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.
  • Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.
  • Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
  • Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).
  • Patients considered psychologically/psychiatrically unsuitable.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jane Littleton, CRNP, MSN contact

410-955-6875

jlittl38@jhmi.edu

TBD TBD contact

443-287-7848

United States1 site, 1 recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

    Carisa Cooney, MPH,CCRP, 443-287-4629, ccooney3@jhmi.edu

    TBD TBD, 443-287-7848

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Monoclonal Antibody (Humanized Anti-CD52), Tacrolimus, Penile Allotransplantation
Keywords
Penile Transplant, Vascularized Composite Allotransplantation (VCA), Composite Tissue Allotransplantation (CTA), Penis, Amputation, Immunosuppression, Composite Tissue, Male, Humans, Allotransplantation, Micropenis, Severely Aambiguous Male Genitalia, congenital/birth defect
Medical subject headings
Wounds and Injuries, Amputation, Traumatic, Congenital Abnormalities, Penis agenesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monoclonal Antibody (Humanized Anti-CD52)Biological

  • TacrolimusDrug

  • Penile AllotransplantationProcedure or surgery

Study groups in NCT02395497
Study groupRoleWhat they receive
Treatment: TransplantationExperimentalPenile transplantation with an immunomodulatory protocol consisting of monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.
Receives: Biological: Monoclonal Antibody (Humanized Anti-CD52); Drug: Tacrolimus; Procedure: Penile Allotransplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Transplantation through end of study period (up to 5 years)

Secondary outcomes (9)

  1. 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.

    Measured: Transplantation through end of study period ( 5 years)

  2. 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.

    Measured: Transplantation through end of study period (up to 5 years)

  3. 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

    Measured: Transplantation through end of study period (up to 5 years)

  4. 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.

    Measured: Transplantation through end of study period (up to 5 years)

  5. 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

    Measured: Transplantation through end of study period ( 5 years)

  6. 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.

    Measured: Transplantation through end of study period ( 5 years)

  7. 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.

    Measured: Transplantation through end of study period ( 5 years)

  8. 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.

    Measured: Transplantation through end of study period ( 5 years)

  9. 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.

    Measured: Transplantation through end of study period ( 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2034 (estimated)
  4. Study completionJun 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395497
Sponsor's protocol ID
NA_00089306
Status last verified
Jul 2026
First submitted
17 Mar 2015
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Schneeberger S, Gorantla VS, Brandacher G, Zeevi A, Demetris AJ, Lunz JG, Metes DM, Donnenberg AD, Shores JT, Dimartini AF, Kiss JE, Imbriglia JE, Azari K, Goitz RJ, Manders EK, Nguyen VT, Cooney DS, Wachtman GS, Keith JD, Fletcher DR, Macedo C, Planinsic R, Losee JE, Shapiro R, Starzl TE, Lee WP. Upper-extremity transplantation using a cell-based protocol to minimize immunosuppression. Ann Surg. 2013 Feb;257(2):345-51. doi: 10.1097/SLA.0b013e31826d90bb.

    PubMed 23001085

  • Bluebond-Langner R, Redett RJ. Phalloplasty in complete aphallia and ambiguous genitalia. Semin Plast Surg. 2011 Aug;25(3):196-205. doi: 10.1055/s-0031-1281489.

    PubMed 22851911

  • Massanyi EZ, Gupta A, Goel S, Gearhart JP, Burnett AL, Bivalacqua TJ, Redett RJ. Radial forearm free flap phalloplasty for penile inadequacy in patients with exstrophy. J Urol. 2013 Oct;190(4 Suppl):1577-82. doi: 10.1016/j.juro.2012.12.050. Epub 2012 Dec 25.

    PubMed 23270911

  • Tuffaha SH, Sacks JM, Shores JT, Brandacher G, Lee WPA, Cooney DS, Redett RJ. Using the dorsal, cavernosal, and external pudendal arteries for penile transplantation: technical considerations and perfusion territories. Plast Reconstr Surg. 2014 Jul;134(1):111e-119e. doi: 10.1097/PRS.0000000000000277.

    PubMed 24622570

  • Schneeberger S, Landin L, Jableki J, Butler P, Hoehnke C, Brandacher G, Morelon E; ESOT CTA Working Group. Achievements and challenges in composite tissue allotransplantation. Transpl Int. 2011 Aug;24(8):760-9. doi: 10.1111/j.1432-2277.2011.01261.x. Epub 2011 May 9.

    PubMed 21554424

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Monoclonal Antibody (Humanized Anti-CD52), Tacrolimus and Penile Allotransplantation in people with Amputation and Wounds and Injuries, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jane Littleton, CRNP, MSN (410-955-6875, jlittl38@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Allograft Survival (time frame: Transplantation through end of study period (up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395497, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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Human Penile Allotransplantation (NCT02395497) | AzTrials