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Human Partial Facial Allotransplantation

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00663988
First received: April 20, 2008
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pharmaceutical Preparations
 Procedure: human transplantation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Human Partial Facial Allotransplantation

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • improved health [ Time Frame: 1 M ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement of abnormal states [ Time Frame: 3 Y ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: III
The effect of human partial facial allotransplantation
 Procedure: human transplantation
Allograft composite tissue transplantation. procedure. medication
Other Name: face allograft

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • normal function of heart/liver/kidney

    • donor: same boold type
    • at least 3 sites were matched within 6 HLA sites

Exclusion Criteria:

  • abnormal function of heart/liver/kidney

    • donor: not the same boold type and 1 or 2 sites were matched within 6 HLA sites
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663988

Locations
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Shuzhong Guo, Dr Xijing Hospital
  More Information

Publications:

Responsible Party: Guo Shuzhong, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00663988     History of Changes
Other Study ID Numbers: XJ-GuoSZ0709
Study First Received: April 20, 2008
Last Updated: April 20, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
face transplantation

ClinicalTrials.gov processed this record on May 23, 2013