Status:
RECRUITING
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Lead Sponsor:
Linda Cendales
Conditions:
Immunosuppression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had l...
Eligibility Criteria
Inclusion
- Patients from 18-65 years old with loss of limb
- Willingness and legal ability to give informed consent
- Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail
Exclusion
- Any condition that precludes serial follow-up
- Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data
- Any active malignancy or any history of a malignancy or lymphoma
- Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02310867
Start Date
March 1 2015
End Date
June 1 2028
Last Update
April 2 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710