Craniomaxillofacial and Upper Extremity Allotransplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated all required Institutional Review Board (IRB) approved consent forms.

Male or female recipient between the ages of 18-64 years. Recipients do not need to be of the same sex as the donor.

Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.

Missing part of one or both hands and forearms.

Disqualifiers

Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation

Serious co-morbidities

Positive serology for HIV; Hepatitis B Antigen

Active malignancy within 5 years with the exclusion of non-melanoma

Trial design

Design model

Single group

Treatments tested in this trial

  • Combined Craniomaxillofacial and Upper Extremity Allotransplantation

    Procedure/Surgery

    Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in function of the transplanted facial segment

This will be measured using electromyogram (EMG)

Time frame
Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
2

Change in function of the transplanted facial segment

This will be measured using nerve conduction studies (NCS)

Time frame
Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
3

Change in function of the transplanted facial segment

This will be measured using computerized tomography angiogram (CTA)

Time frame
Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
4

Change in function of the transplanted facial segment

This will be measured using magnetic resonance imaging (MRI)

Time frame
Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.