Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Launched by LINDA CENDALES · Dec 5, 2014

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of hand transplantation for people who have lost a limb below the elbow. The goal is to see if patients can use the transplanted hand in their daily activities after 18 months. To participate, you need to be between 18 and 65 years old, have experienced limb loss, and be willing to travel for study visits, which will include various health assessments like blood tests and x-rays.

If you join the study, you will have several visits over the course of 18 months where your health and the function of the transplanted hand will be monitored. While there are risks involved, such as the possibility of rejection of the new hand or infection, your personal information will be kept secure. This trial aims to gather important data that can help improve limb loss treatment in the future, and you will be contributing to research that could benefit many others.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients from 18-65 years old with loss of limb
• • 2. Willingness and legal ability to give informed consent
• • 3. 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 Criteria:
• • 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)