Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
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|ClinicalTrials.gov Identifier: NCT02310867|
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : April 7, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Immunosuppression||Drug: Belatacept Procedure: Hand transplant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: Hand transplant with Belatacept||
This study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant. Nulojix® (belatacept) is approved by the FDA for use in kidney transplants; however, it is investigational in this study.
Other Name: Nulojix
Procedure: Hand transplant
The purpose of this study is to see if a surgical procedure for transplantation of a hand from a deceased donor can help subjects perform daily living activities better than they are currently able to do.
- Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test. [ Time Frame: 18 months ]
- Clinical rejection [ Time Frame: 18 months ]Presence of macroscopic changes in the skin like a rash
- Histological rejection [ Time Frame: 18 months ]Presence of infiltrates categorized by the Banff classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310867
|Contact: Linda Cendales, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Linda Cendales, MD||Duke University|