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NCT01853111 · ClinicalTrials.gov registry record · Phase 1
Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01853111: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT01853111 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01853111, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. These patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs became available to this patients. Unfortunately, at this juncture, patients who receive VCA must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. Transplant recipients with immune tolerance do not need to take immunosuppression drugs. The investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.
Interventions
- BIOLOGICAL Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2020-03-10 |
| Phase | Phase 1 |
What the finished NCT01853111 record still lists
NCT01853111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Interleukin-2 is the first listed.
NCT01853111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01853111 about?
NCT01853111 is a clinical study titled "Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants". Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascula...
What is the current status of trial NCT01853111?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2014-03-01. Estimated completion is 2020-03-10.
What interventions are being tested in trial NCT01853111?
The interventions under investigation include: Interleukin-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01853111?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01853111's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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