Human Upper Extremity Allotransplantation: F/U Protocol

Johns Hopkins University

Status: Enrolling

Conditions: Amputation, Traumatic; Hand Injuries; Wounds and Injury

Study type: Observational

Funder types: Other

Identifiers

NCT03400345

NA_00068053

Details and patient eligibility

About

Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
• Completes the protocol informed consent form.
• Consents to sample collection and storage (biopsies).
• USA citizen or equivalent.
• Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Exclusion criteria

• Candidate has not received an upper extremity allotransplant.
• Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.