Actively Recruiting

Age: 18Years - 100Years
All Genders
ID03400345

Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

Led by Johns Hopkins University · Updated on 2026-05-11

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the long-term outcomes of upper extremity allotransplantation, a procedure where a transplanted hand or arm is attached to a patient. This research is important to monitor the safety of the surgery and the immunosuppressive treatments used to prevent rejection. The study aims to collect ongoing data to better understand patient quality of life and functional outcomes following this complex transplant. The study involves follow-up assessments of patients who have undergone unilateral or bilateral upper limb transplantation at least five years prior. Participants agree to ongoing monitoring, including sample collection like biopsies, and adherence to immunomodulatory treatment plans. The research team evaluates various measures of hand function, psychological well-being, and physical health over approximately five years post-enrollment. Participants will have regular evaluations using questionnaires assessing hand function, pain, psychological health, and quality of life. Additional tests include antibody monitoring, skin biopsies, CT angiography, and MR neurography, performed annually for five years. These assessments help researchers track changes from baseline to understand the impact of transplantation and treatments. Patient commitment to the protocol and immunosuppressive therapy is required throughout the study period.

CONDITIONS

Brief Title

Human Upper Extremity Allotransplantation: F/U Protocol

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 5 years post-enrollment (±90 days)

Participants who have received unilateral or bilateral upper limb transplants are observed and assessed to monitor quality of life and transplant health over time.

Annual visits for up to 5 years

Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

J

Jane Littleton, C.R.N.P

T

TBD TBD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial