Craniomaxillofacial and Upper Extremity Allotransplantation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04057638
Status
Recruiting
Apply to this trial

Conditions

  • Craniofacial Injuries
  • Face Injuries
  • Facial Deformity
  • Facial Injuries
  • Hand Injuries
  • Upper Extremity Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Combined Craniomaxillofacial and Upper Extremity Allotransplantation — PROCEDURE
    Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Study Details

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.

Key Dates

Start date
Jun 17, 2019
Status verified
Dec 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.

Primary Outcome Measure

Change in function of the transplanted facial segment [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10017
Elie Ramly, MD
[email protected]
929-455-5824
Thomas Calahan, BA
[email protected]
9294555826
Eduardo Rodriguez, MD, DDS (PRINCIPAL_INVESTIGATOR)
Allyson Alfonso, BS (SUB_INVESTIGATOR)
Jonathan Bass, MD (SUB_INVESTIGATOR)
Aileen Blitz, MD (SUB_INVESTIGATOR)
Arthur Kaplan, PhD (SUB_INVESTIGATOR)
Daniel Ceradini, MD (SUB_INVESTIGATOR)
David Chiu, MD (SUB_INVESTIGATOR)
Mihye Choi, MD (SUB_INVESTIGATOR)
Roberto Flores, MD (SUB_INVESTIGATOR)
Bruce Gelb, MD (SUB_INVESTIGATOR)
Alyssa Golas, MD (SUB_INVESTIGATOR)
Jacques Hacquebord, MD (SUB_INVESTIGATOR)
Jamie Levine, MD (SUB_INVESTIGATOR)
Elie Ramly, MD (SUB_INVESTIGATOR)
Allison Rojas, MS, RN (SUB_INVESTIGATOR)
Stephen Ross, MD (SUB_INVESTIGATOR)
Pierre Saadeh, MD (SUB_INVESTIGATOR)
Sheel Sharma, MD (SUB_INVESTIGATOR)
David Staffenberg, MD (SUB_INVESTIGATOR)
Vishal Thanik, MD (SUB_INVESTIGATOR)

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