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Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
NCT02310867 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Belatacept
- PROCEDURE Hand transplant
Study Locations (1)
North Carolina
- Duke University Medical Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-03 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02310867
The ClinicalTrials.gov registry entry for NCT02310867 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Linda Cendales, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Immunosuppression appearing as the primary indexed condition, and to 2 interventions — of which Belatacept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02310867 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02310867 about?
NCT02310867 is a clinical study titled "Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy". 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 ...
What is the current status of trial NCT02310867?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2015-03. Estimated completion is 2028-06.
What conditions does trial NCT02310867 study?
This clinical trial studies the following conditions: Immunosuppression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02310867?
The interventions under investigation include: Belatacept (DRUG), Hand transplant (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02310867?
This trial is sponsored by Linda Cendales, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02310867 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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