NCT03400345 Human Upper Extremity Allotransplantation: F/U Protocol
| NCT ID | NCT03400345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Amputation, Traumatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2017-07-25 |
| Primary Completion | 2036-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2017-07-25 with a primary completion date of 2036-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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). * 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.
Contact & Investigator
Damon Cooney, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03400345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Amputation, Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03400345 currently recruiting?
Yes, NCT03400345 is actively recruiting participants. Contact the research team at jlittl38@jhmi.edu for enrollment information.
Where is the NCT03400345 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03400345 clinical trial?
NCT03400345 is sponsored by Johns Hopkins University. The principal investigator is Damon Cooney, M.D., Ph.D. at Johns Hopkins University. The trial plans to enroll 60 participants.