Human Partial Facial Allotransplantation - Full Text View

Sponsored by:	Xijing Hospital
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00663988

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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
III: Experimental The effect of human partial facial allotransplantation	Procedure: human transplantation Allograft composite tissue transplantation. procedure. medication

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:

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. No abstract available.

Dubernard JM, Lengelé B, Morelon E, Testelin S, Badet L, Moure C, Beziat JL, Dakpé 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, Francès 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.

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

Keywords provided by Xijing Hospital:

face transplantation

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on May 07, 2009