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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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