Purpose of this Study
We are doing this study to understand how hand transplantation can help you with your daily activities compared to before the transplant.
Who Can Participate?
Eligibility
- Adults 18 - 60
- One or both limb loss
- One or both limb loss
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study you will:
- Have a hand transplant
- Take the study drug, Nulojix (a drug that is used in other transplants to help stop your body from rejecting the hand)
- Complete follow-up visits for 18 months after the surgery, and at least once a year after surgery
- Get blood drawn
- Have biopsies
- Complete questionnaires
- Have x-rays/CT pictures of your hand
- Have a hand transplant
- Take the study drug, Nulojix (a drug that is used in other transplants to help stop your body from rejecting the hand)
- Complete follow-up visits for 18 months after the surgery, and at least once a year after surgery
- Get blood drawn
- Have biopsies
- Complete questionnaires
- Have x-rays/CT pictures of your hand
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Study Website
Principal Investigator
Linda
Cendales-Behaine
Protocol Number
PRO00056079
NCT ID
NCT02310867
Phase
II
Enrollment Status
OPEN TO ACCRUAL