Human Penile Allotransplantation
Recruiting
Phase 2
Phase 3
Interventional Study
Amputation
Wounds and Injuries
Amputation, Traumatic
Urologic Surgical Procedures, Male
Amputation, Traumatic/Surgery
Penis/Transplantation
Penis/Surgery
Penis/Injuries
Congenital Anomaly, Male Genitalia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 69
- Sex
- Male
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Johns Hopkins University · Other
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About This Trial
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, ero…
Trial Locations
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Eligibility Criteria
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 lymph…
Contacts
TBD TBD
443-287-7848
CONTACT