Improving hand transplantation for patients with limb loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of hand transplantation for individuals who have lost a limb below the elbow. It will involve a series of assessments over 18 months, including medical history, vital signs, and functional tests to measure the ability to use the transplanted hand in daily activities. Participants will receive immunomodulatory treatment with Belatacept to enhance graft integration and reduce the risk of rejection. The study will focus on the long-term outcomes of hand function and quality of life for these patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Linda Cendales, MD — Duke University
• Study coordinator: Linda Cendales, MD
• Email: linda.cendales@duke.edu
• Phone: 919-681-7514

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.