Improving hand transplantation for patients with limb loss
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
This study is testing if hand transplants can help people who have lost a hand below the elbow to use their new hand better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT02310867 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have experienced loss of a limb below the elbow and are willing to participate in the study.
Not a fit: Patients with active malignancies, severe comorbid conditions, or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients with limb loss by enabling them to regain functional use of a transplanted hand.
How similar studies have performed: Other studies have shown promise in hand transplantation and immunomodulation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.