Hand Transplant for Traumatic Amputation

Overseen By Jane Littleton, C.R.N.P

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Immunomodulatory drugs

Disqualifiers: No transplant, Noncompliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Initial surgery and immediate post-operative care

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather important data about the safety and effectiveness of upper limb transplants, focusing specifically on the surgery and the medication needed to prevent rejection. Researchers seek to understand the long-term effects of these transplants on patients' lives. The trial is open to individuals who received a single or double arm transplant at least five years ago and are committed to following the treatment plan. Participants will contribute to improving knowledge and outcomes for future transplant patients. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment benefits more patients, offering participants a chance to contribute to broader medical knowledge.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, you must agree to follow the immunomodulatory treatment plan, which might affect your current medication routine.

What prior data suggests that this procedure is safe?

Research has shown that transplanting a hand or arm from a donor is generally safe for patients. Studies indicate that the survival rate after these transplants exceeds 98%, meaning almost all patients survive the procedure.

However, some cases have involved complications. In past studies, out of 24 known instances where transplanted limbs were lost, a few resulted from multiple complications. It's important to understand that these complications are uncommon.

Overall, the goal is to continue improving safety and effectiveness. Ongoing research is essential, as it helps doctors learn how to make these transplants even safer and more successful for future patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about upper extremity allotransplantation because it offers a revolutionary approach to restoring function and sensation in individuals who have lost their arms. Unlike prosthetic limbs, which can often be limited in functionality and sensation, this treatment involves transplanting a donor arm, providing the potential for a more natural and comprehensive restoration of movement and touch. This method could dramatically improve quality of life by integrating the transplanted limb into the body's existing systems, allowing for a seamless connection to the nervous and circulatory systems. This treatment is particularly promising because it aims to offer not just mechanical function, but also the return of sensory feedback, which is a significant advancement over current prosthetic options.

What evidence suggests that upper extremity allotransplantation is effective?

Research has shown that transplanting a new hand or arm can greatly enhance a patient's quality of life. Approximately 75% of patients reported improvements, and many returned to work. Early results indicate that the new hand or arm functions effectively, with scores ranging from 24 to 70, depending on whether the hand is dominant. Patients also experienced a strong connection and sense of ownership with their new limbs. Despite risks such as infection and metabolic issues, many patients expressed high satisfaction with the procedure. ^{2 3 6 7 8}

Who Is on the Research Team?

Jaimie Shores, M.D.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Upper Extremity Allotransplantation

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4094126/

Upper extremity transplantation: current concepts and ... Based on data form the 2010 report, quality of life improved in 75 % of patients, and most were able to return to work. HTSS scores averaged 52 at 1 year and 88 ...

2. link.springer.com link.springer.com/article/10.1007/s10856-017-5880-0

Outcomes after hand and upper extremity transplantation All patients achieved good functional outcomes in the early post-transplant period with Carroll scores ranging from 24 to 70 for dominant and 18 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325007208

Measuring Health-Related Quality of Life in Upper ... These PRO items offer a structured way to measure health-related quality of life outcomes for UE VCA from the perspective of the recipients, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7756600/

Long‐term outcome after hand and forearm transplantation All patients successfully assimilated the transplanted hand(s) into their body‐/self‐image and were able to develop a sense of “ownership”. They reported a high ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01459107

NCT01459107 | Human Upper Extremity Allotransplantation Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25401735/

Hand and upper extremity transplantation: an update of ... Results: Although 24 losses (including four mortalities) are known, three of the four reported mortalities and eight of 24 limb losses were caused by multiple ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00722280

Human Upper Extremity (Hand and Forearm ... Overall Goal. To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations.

8. amjtransplant.org amjtransplant.org/article/S1600-6135(22)22327-2/fulltext

Hand transplantation in the United States: A review ... Of patients transplanted after 2014, posttransplant functional scores included a decrease in Disabilities of the Arm, Shoulder and Hand questionnaire in 3 of 10 ...