NCT00663988

Brief Summary

Progress in composite tissue allotransplantation provides a new remedy for severely disfigured patients. We plan to carry out allograft composite tissue transplantation after a careful systemic preparation.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

April 22, 2008

Status Verified

February 1, 2006

Enrollment Period

Same day

First QC Date

April 20, 2008

Last Update Submit

April 20, 2008

Conditions

Pharmaceutical Preparations

Keywords

face transplantation

Outcome Measures

Primary Outcomes (1)

  • improved health

    1 M

Secondary Outcomes (1)

  • improvement of abnormal states

    3 Y

Study Arms (1)

III

EXPERIMENTAL

The effect of human partial facial allotransplantation

Procedure: human transplantation

Interventions

human transplantationPROCEDURE

Allograft composite tissue transplantation. procedure. medication

Also known as: face allograft
III

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • normal function of heart/liver/kidney
  • donor: same boold type
  • at least 3 sites were matched within 6 HLA sites

You may not qualify if:

  • abnormal function of heart/liver/kidney
  • donor: not the same boold type and 1 or 2 sites were matched within 6 HLA sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

  • Dubernard JM, Lengele B, Morelon E, Testelin S, Badet L, Moure C, Beziat JL, Dakpe S, Kanitakis J, D'Hauthuille C, El Jaafari A, Petruzzo P, Lefrancois N, Taha F, Sirigu A, Di Marco G, Carmi E, Bachmann D, Cremades S, Giraux P, Burloux G, Hequet O, Parquet N, Frances C, Michallet M, Martin X, Devauchelle B. Outcomes 18 months after the first human partial face transplantation. N Engl J Med. 2007 Dec 13;357(24):2451-60. doi: 10.1056/NEJMoa072828.

    PMID: 18077810BACKGROUND

  • Xudong Z, Shuzhong G, Yan H, Datai W, Yunzhi N, Linxi Z. A hemifacial transplantation model in rabbits. Ann Plast Surg. 2006 Jun;56(6):665-9. doi: 10.1097/01.sap.0000202829.24619.19. No abstract available.

    PMID: 16721082RESULT

MeSH Terms

Interventions

TSTA3 protein, human

Study Officials

  • Shuzhong Guo, Dr

    Xijing Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2008

First Posted

April 22, 2008

Study Start

April 1, 2006

Primary Completion

April 1, 2006

Last Updated

April 22, 2008

Record last verified: 2006-02

Locations

CN(1)