BridgeMD
New treatment option for Amputation
Official title Human Penile Allotransplantation
ClinicalTrials.gov ID: NCT02395497
What this study is testing
What is Monoclonal Antibody (Humanized Anti-CD52)?
Monoclonal Antibody (Humanized Anti-CD52) is an investigational medicine, being studied as a potential treatment for amputation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69, men only
You may be able to join if
- Donor
- 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).
You likely can't join if
- Untreated sepsis.
- HIV (active or seropositive).
- Active tuberculosis.
- Active Hepatitis B infection.
- Hepatitis C.
- Viral encephalitis.
See the full eligibility criteria
- Donor
- 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
- 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...
- 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
- 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...
- Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).
- Patients considered psychologically/psychiatrically unsuitable.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.