Actively Recruiting
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Led by Linda Cendales · Updated on 2026-04-09
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of hand transplantation as a treatment for people who have lost a limb below the elbow. This Phase 2 study focuses on whether patients can use the transplanted hand in everyday activities 18 months after the procedure. The study also tests a new immunosuppressant drug called Belatacept, which is already approved for kidney transplants but is investigational here for preventing rejection in hand transplants. Participants will receive a hand transplant from a deceased donor and be treated with Belatacept to help prevent rejection. The study involves multiple visits over 18 months for assessments, including medical history, vital signs, psychosocial evaluations, urine and blood tests, chest X-rays, bone density scans, and biopsies. The research team collects detailed data on recipient and donor information, transplant history, range of motion, sensation, and immunosuppressive medications. During the study, participants will be closely monitored for their ability to use the transplanted limb and signs of rejection through clinical and tissue evaluations. Researchers will use a quantitative functional test at 18 months to measure daily living activity use. Safety assessments include monitoring for infection, rejection, and risks related to procedures like blood draws and biopsies. All personal data are securely handled according to strict privacy standards, with participation lasting 18 months.
CONDITIONS
Brief Title
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years with loss of limb below the elbow
- Willing and legally able to give informed consent
- Willingness to travel to study site for protocol-specific sample collection or ability to send samples by overnight mail
You will not qualify if you...
- Any condition preventing serial follow-up
- Any condition increasing risk of participation or complicating data interpretation
- Any active malignancy or history of malignancy or lymphoma
- Inability or unwillingness to comply with protocol monitoring, therapy, or immunodeficiency syndromes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo hand transplantation surgery followed by immediate post-operative care.
1 surgery visit and several in-hospital visits
Duration - Up to 18 months
Participants receive the immunosuppressant drug Belatacept to prevent rejection of the transplanted hand.
Regular visits for drug administration and monitoring as per protocol
Duration - Up to 18 months following transplantation
Participants are monitored for clinical and histological signs of rejection and overall limb function.
Multiple follow-up visits during treatment period
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
L
Linda Cendales, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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