Follow-up on upper limb transplant patients
Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol
This study looks at how well upper limb transplants are working for patients who had the surgery at least five years ago, focusing on their safety and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03400345 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have undergone upper extremity allotransplantation, a procedure that is gaining traction in the U.S. The Johns Hopkins Hand/Arm Transplantation Team aims to collect ongoing data to assess the safety of the procedure and the effectiveness of the immunosuppression protocol. By enrolling patients who are at least five years post-transplant, the study seeks to quantify patient outcomes and improvements in quality of life over time.
Who should consider this trial
Good fit: Ideal candidates are individuals who are at least five years post-unilateral or bilateral upper limb transplantation.
Not a fit: Patients who have not received an upper extremity allotransplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of upper limb transplantation and improve patient care and outcomes.
How similar studies have performed: While upper extremity allotransplantation is a relatively new field, ongoing data collection is crucial for understanding its long-term effects, and similar studies have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Damon Cooney, M.D., Ph.D. — Johns Hopkins University
- Study coordinator: Jane Littleton, C.R.N.P
- Email: jlittl38@jhmi.edu
- Phone: 410-955-6875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.