Clinical trial NCT02310867: Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Official title: Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Immunosuppression
Keywords: hand transplantation, amputation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Primary outcomes:
measure: Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
timeFrame: 18 months
Secondary outcomes:
measure: Clinical rejection
timeFrame: 18 months
measure: Histological rejection
timeFrame: 18 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Linda Cendales, MD
role: PRINCIPAL_INVESTIGATOR
References: