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NCT01889381 · ClinicalTrials.gov registry record · Phase 2
Human Craniomaxillofacial Allotransplantation
A Phase 2 study of Facial Injuries and Craniofacial Injuries, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01889381: Recruiting Phase 2 study of Facial Injuries and Craniofacial Injuries, sponsored by Johns Hopkins University.
NCT01889381 is a Phase 2 study of Facial Injuries and Craniofacial Injuries that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 168-participant average among 3 other Facial Injuries trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01889381, a Phase 2 study of Facial Injuries and Craniofacial Injuries, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of face transplantation. Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries/ defects by minimizing maintenance immunosuppression therapy in face transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 15 full or partial human face transplants employing this novel protocol. Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement
Primary Outcome
Post-operative graft survival will be documented monthly Months 1-12 and quarterly (every 3 months) Years 2-5.
Conditions Studied
Interventions
- DRUG Bone marrow cell-based therapy & 1-drug immunosuppression.
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-08 |
| Est. Completion | 2031-08 |
| Phase | Phase 2 |
What NCT01889381 shows while recruiting
NCT01889381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 168-participant average among 3 other Facial Injuries trials with a reported enrollment target (91% lower).
The record links to 6 conditions, with Facial Injuries appearing as the primary indexed condition, and to 1 intervention - of which Bone marrow cell-based therapy & 1-drug immunosuppression. is the first listed.
NCT01889381 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01889381 about?
NCT01889381 is a clinical study titled "Human Craniomaxillofacial Allotransplantation". Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although curr...
What is the current status of trial NCT01889381?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2012-08. Estimated completion is 2031-08.
What conditions does trial NCT01889381 study?
This clinical trial studies the following conditions: Facial Injuries, Craniofacial Injuries, Facial Deformity, Traumatic Wounds and Injuries, Craniofacial Defects.
What interventions are being tested in trial NCT01889381?
The interventions under investigation include: Bone marrow cell-based therapy & 1-drug immunosuppression. (DRUG).
Who is sponsoring clinical trial NCT01889381?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01889381 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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