Trials / Recruiting
RecruitingNCT04057638
Craniomaxillofacial and Upper Extremity Allotransplantation
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.
Detailed description
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper extremity constitutes the part of the body including arm, forearm and hand. This procedure is called combined craniomaxillofacial and upper extremity allotransplantation or "combined face and upper extremity transplant". This study will also collect data on how patients do during and after having a combined face and upper extremity transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits. Participants are invited to take part in this research study who have suffered severe injury to the face and upper extremity and previous surgeries to repair the injury have not restored function, appearance, and sensation. Participants must have attempted a trial of prosthetics (artificial upper extremity), if at all possible.
Conditions
- Face Injuries
- Hand Injuries
- Craniofacial Injuries
- Upper Extremity Injuries
- Facial Injuries
- Facial Deformity
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Combined Craniomaxillofacial and Upper Extremity Allotransplantation | Combined Craniomaxillofacial and Upper Extremity Allotransplantation |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2019-08-15
- Last updated
- 2025-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04057638. Inclusion in this directory is not an endorsement.