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Combined Craniomaxillofacial and Upper Extremity Allotransplantation for Craniofacial Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Craniofacial Injury+5 MoreCombined Craniomaxillofacial and Upper Extremity Allotransplantation - Procedure
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to reconstruct faces and upper extremities using a combination of skin, bone, muscle, and blood vessels from donors. The goal is to improve function and appearance for patients who haven't had success with other methods.

Eligible Conditions
  • Craniofacial Injury
  • Facial Injuries
  • Hand Injuries
  • Facial Disfigurement
  • Upper Extremity Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

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dexamethasone

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

Year 5
Change in appearance of the transplanted facial segment
Change in appearance of the upper extremity transplant
Change in function of the transplanted facial segment
Change in function of the upper extremity transplant

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Valiant PS-IDE Stent Graft
1
ENSEAL X1 Curved Jaw
2
dexamethasone

Trial Design

1 Treatment Group

Treatment group
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Combined Craniomaxillofacial and Upper Extremity Allotransplantation · No Placebo Group · N/A

Treatment group
Procedure
Experimental Group · 1 Intervention: Combined Craniomaxillofacial and Upper Extremity Allotransplantation · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: monthly for 6 months, every 6 months for 2 years, then annually up to year 5

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,264 Previous Clinical Trials
753,581 Total Patients Enrolled
Eduardo Rodriguez, MD, DDSPrincipal InvestigatorNYU Langone Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18-64 years
Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in upper extremity reconstruction.
You are willing to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery.
You are able to complete pre-transplant examination and screening procedures.
References

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