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|ClinicalTrials.gov Identifier: NCT02476838|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2015
Last Update Posted : June 18, 2018
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to living individual will help restore greater function, appearance, and sensation to the hand and forearm areas of individuals who have suffered traumatic injury to the hand and forearm.
This procedure is called a hand allotransplantation or "hand transplant".
This study will also collect data on how patients do during and after having a hand transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Procedure: Hand Transplantation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microvascular VCA Transplantation|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
traumatic amputation of the hand
may be male or female patients between the ages of 18 and 60 who are missing all or part of one or both hands and forearms
Procedure: Hand Transplantation
microvascular VCA transplant
- Number and proportion of subjects with biopsy-proven rejection [ Time Frame: 60 months ]
- Number and proportion losing their VCA graft [ Time Frame: 60 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476838
|Contact: Nicole Sweeney, NP||(646) 501-4464||Nicole.Sweeney@nyumc.org|
|Contact: Tiffany Drummondfirstname.lastname@example.org|