Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 69Years
MALE
ID02395497

Human Penile Allotransplantation Using Immunomodulatory Protocol to Improve Function and Quality of Life

Led by Johns Hopkins University · Updated on 2025-07-07

60

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying penile allotransplantation to improve the reconstruction and function of the penis in men who have lost their penis due to battle, traumatic injury, or cancer. Current reconstructive surgery often cannot fully restore appearance, sensation, or erectile function, and can involve multiple operations with risks of complications. This clinical trial aims to evaluate the feasibility, function, and quality of life outcomes of penile transplants using a specialized immune treatment protocol, comparing results to traditional reconstructive methods. The study involves penile transplantation combined with an immunomodulatory protocol that includes induction therapy with a monoclonal antibody (humanized anti-CD52), donor bone marrow infusion, and maintenance immunosuppression with tacrolimus monotherapy without steroids. This approach is designed to promote graft survival while reducing the intensity of immune suppression. The trial is non-randomized and self-controlled, focusing on Wounded Warriors and civilians, and aims to demonstrate improved outcomes up to 5 years post-transplant compared to conventional reconstruction. Participants will undergo assessments of graft survival and multiple quality of life measures including psychological, sexual function, and pain evaluations throughout the study period of up to 5 years. Researchers will monitor functional return, patient satisfaction, and complication rates. The study includes extensive follow-up to assess physical and psychological benefits, with regular questionnaires and clinical evaluations to measure success and patient well-being over time.

CONDITIONS

Brief Title

Human Penile Allotransplantation

Who Can Participate

Age: 18Years - 69Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male recipients aged 18 to 69 years
  • Recent or remote penile injury resulting in loss of 75% or more of the penis
  • Penectomy due to penile cancer or penile cancer survivors over 5 years
  • Micropenis with congenital or birth defect and severe ambiguous male genitalia
  • Completed clinic appointment with a study surgeon to discuss reconstructive options
  • Signed informed consent for the study protocol
  • No co-existing medical conditions or psychosocial problems that affect treatment or results
  • Negative for malignancy in past 5 years and HIV negative at transplant
  • Negative crossmatch with donor and consent to sample collection and bone marrow infusion
  • U.S. citizen or equivalent
  • Commitment to immunomodulatory treatment regimen
Not Eligible

You will not qualify if you...

  • Untreated sepsis or active infections including HIV, tuberculosis, hepatitis B or C, viral encephalitis, toxoplasmosis
  • Malignancy within past 5 years
  • Recent intravenous drug abuse within 3 months
  • Paralysis due to ischemic or traumatic origin
  • Inherited or toxic neuropathies and inflammatory neuropathies
  • Mixed connective tissue disease
  • Severe deforming rheumatoid or osteoarthritis in limbs
  • Donor exclusion for active HSV-2 infection or recent non-professional or identifiable tattoos
  • Recipient exclusion for conditions increasing immunosuppression risk or surgical complications
  • Sensitized recipients with high levels of HLA antibodies
  • Coagulopathies and blood disorders impacting surgery or recovery
  • Psychological or psychiatric unsuitability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks or until discharge

Participants undergo penile allotransplantation surgery followed by immediate post-operative care including immunomodulatory induction therapy using monoclonal antibody and donor bone marrow infusion.

1 surgery visit and follow-up visits during hospitalization

Treatment

Duration - Up to 5 years

Participants receive tacrolimus monotherapy as part of the immunomodulatory protocol to maintain graft survival and improve function and quality of life.

Regular visits for monitoring throughout treatment period

Follow-up

Duration - Up to 5 years

Participants are monitored long-term for graft survival, quality of life, psychosexual, and psychological outcomes after treatment.

Periodic visits for assessments after active treatment

Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

J

Jane Littleton, CRNP, MSN

T

TBD TBD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Using the dorsal, cavernosal, and external pudendal arteries for penile transplantation: technical considerations and perfusion territories.

Sami H Tuffaha, Justin M Sacks, Jaimie T Shores...

https://pubmed.ncbi.nlm.nih.gov/24622570