60 Participants Needed

Human Upper Extremity Allotransplantation: F/U Protocol

TT
JL
Overseen ByJane Littleton, C.R.N.P
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
Must be taking: Immunomodulatory drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

JS

Jaimie Shores, M.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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).
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo upper extremity allotransplantation and receive immunosuppression protocol

Initial surgery and immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and quality of life post-transplantation

5 years
Annual visits for assessments

Long-term follow-up

Ongoing data collection for research purposes to assess long-term safety and outcomes

Beyond 5 years

Treatment Details

Interventions

  • Upper Extremity Allotransplantation

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Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
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Recruited
15,160,000+
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