NCT02310867 Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
| NCT ID | NCT02310867 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Linda Cendales |
| Condition | Immunosuppression |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2015-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2015-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test. Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation. Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).
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)
Contact & Investigator
Linda Cendales, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT02310867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Immunosuppression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02310867 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02310867 currently recruiting?
Yes, NCT02310867 is actively recruiting participants. Contact the research team at linda.cendales@duke.edu for enrollment information.
Where is the NCT02310867 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT02310867 clinical trial?
NCT02310867 is sponsored by Linda Cendales. The principal investigator is Linda Cendales, MD at Duke University. The trial plans to enroll 50 participants.