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New treatment option for Immunosuppression
Official title Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
ClinicalTrials.gov ID: NCT02310867
What this study is testing
What is Belatacept?
Belatacept is an investigational medicine, given as an once-daily, being studied as a potential treatment for immunosuppression.
Also referred to as Nulojix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients from 18-65 years old with loss of limb
- Willingness and legal ability to give informed consent
- 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
You likely can't join if
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.