Hand Transplantation for Amputation

Overseen By Thomas Calahan

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Uncontrolled infection, Substance abuse, Psychiatric illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hand Transplantation for Amputation?

Research shows that hand transplantation can significantly restore function and appearance, with many patients experiencing improved quality of life and the ability to perform daily activities. Although there are risks like rejection and the need for lifelong medication, most patients achieve protective sensation and muscle recovery, allowing them to return to work and improve their manual skills. ^{1 2 3 4 5}

Is hand transplantation generally safe for humans?

Hand transplantation can restore function and improve quality of life, but it comes with risks like transplant rejection and side effects from lifelong medication. Some patients experience serious complications, including infections and metabolic issues, but life-threatening problems are rare. The decision to undergo this procedure should weigh the potential benefits against these risks. ^{1 2 6 7 8}

How is hand transplantation different from other treatments for hand amputation?

Hand transplantation is unique because it involves transplanting a real hand from a donor, allowing for comprehensive hand function and sensation, unlike prosthetic limbs which have limitations in function and sensation. However, it requires lifelong immunosuppressive therapy to prevent rejection, which is not needed with prosthetics. ^{4 9 10 11 12}

What is the purpose of this trial?

The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to living individual will help restore greater function, appearance, and sensation to the hand and forearm areas of individuals who have suffered traumatic injury to the hand and forearm. This procedure is called a hand allotransplantation or "hand transplant". This study will also collect data on how patients do during and after having a hand transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.

Research Team

Sheel Sharma, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for men and women aged 18-60 who have lost all or part of one or both hands and forearms. They must not have had cancer in the last 5 years, be HIV negative, and not pregnant. Participants should also be willing to use contraception for a year post-transplant, have no severe diseases or psychiatric conditions that could interfere with the transplant's success, and should not have an unstable social situation.

Inclusion Criteria

Crossmatch is negative between donor and recipient

Subjects must give written informed consent

I am not satisfied with or cannot use a prosthetic hand.

Exclusion Criteria

Unstable social situation as evidenced by lack of stable housing and/or lack of a supportive significant other

Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test)

Active severe psychiatric illness such as Psychosis or Depression

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Transplant Waiting List

Participants are placed on a waiting list for a matched donor and provide monthly serum samples for cross-matching

Variable (until matched donor is found)

Monthly visits (in-person)

Transplant Surgery

Participants undergo hand transplant surgery once a matched donor is identified

18-24 hours

1 visit (in-person)

Post-operative Care and Rehabilitation

Participants receive post-operative care and rehabilitation, including occupational therapy and monitoring

90 days in-patient, followed by 12-24 months of occupational therapy

Daily visits during in-patient stay, regular visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits

First year: 6 visits, then at least 2 visits yearly

In-person visits

Treatment Details

Interventions

• Hand Transplantation

Trial Overview The study is testing hand transplantation from deceased donors to see if it can improve function, appearance, and sensation in patients' hands and forearms after traumatic injury. Recovery will be monitored through exams, x-rays, blood tests, tissue tests, and other evaluations during follow-up visits.

Participant Groups

Group I: traumatic amputation of the hand Experimental Treatment 1 Intervention

may be male or female patients between the ages of 18 and 60 who are missing all or part of one or both hands and forearms

Hand Transplantation is already approved in United States, European Union for the following indications:

Approved in United States as Hand Transplantation for:

• Traumatic injury to the hand and forearm

Approved in European Union as Hand Allotransplantation for:

• Bilateral hand amputation
• Dominant hand amputation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Hand transplantation significantly improves function and form for patients with upper extremity amputations, with notable improvements in Disabilities of the Arm, Shoulder and Hand scores, especially for distal transplants.

Despite the benefits, there are risks of acute and chronic rejection, with 57 patients experiencing acute rejection among 96 patients studied, highlighting the need for better management of immunological complications and patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Decades of Hand Transplantation: A Systematic Review of Outcomes. Wells, MW., Rampazzo, A., Papay, F., et al.[2023]

In a review of 24 hand transplantations performed on 18 male patients, both patient and graft survival rates were 100% at 1 and 2 years, highlighting the efficacy of the immunosuppressive therapy used, which included tacrolimus and mycophenolate mofetil.

Despite some cases of acute rejection, all compliant patients experienced reversible rejection episodes, and 90% of recipients returned to work, indicating significant improvements in quality of life and functional recovery after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second report (1998-2006) of the International Registry of Hand and Composite Tissue Transplantation. Lanzetta, M., Petruzzo, P., Dubernard, JM., et al.[2021]

A study involving 22 individuals with upper limb amputations revealed that the adjustment process to amputation significantly affects their interest in upper limb transplantation, with those who adjusted better showing less interest in transplantation.

Understanding the psychosocial and functional adjustments of amputees can help improve patient selection and counseling for upper extremity transplantation, highlighting the complexity of identifying ideal candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustment to amputation and interest in upper limb transplantation. Talbot, SG., Carty, MJ., Jensen, SE., et al.[2022]

Bilateral hand allograft transplantation has been successfully performed in five patients with traumatic amputations, showing promising long-term results with follow-up periods ranging from 3 to 12 years.

Patients demonstrated useful daily function and good psychological acceptance of the transplanted hands, indicating that despite the need for lifelong immunosuppressive therapy, hand allograft transplantation can be a valuable option in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hand allograft transplantation: what are the implications?]. Masquelet, AC.[2021]

In a study of nine patients evaluated for hand transplantation, most chose not to proceed due to concerns about rehabilitation time, the need for immunosuppression, and alternative treatment options, highlighting the complexity of decision-making in non-life-saving procedures.

Patient motivations for considering hand transplantation included dissatisfaction with prosthetics and the desire to improve daily functioning, indicating that quality of life is a significant factor in the decision to pursue or decline such surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Center Retrospective Evaluation of Decision-Making and Factors Motivating Hand Transplant Candidates. Boehmer, KR., Kennedy, CC., Hargraves, IG., et al.[2023]

The first successful hand transplantation demonstrated the surgical technique's feasibility and the effectiveness of the immunosuppressive protocol, with minimal adverse effects and a strong emphasis on patient compliance for recovery.

Following this success, the first double hand transplantation was performed, showing significant sensorimotor recovery in patients, allowing them to perform daily activities and improve their quality of life despite some episodes of acute rejection that were effectively managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World experience after more than a decade of clinical hand transplantation: update on the French program. Petruzzo, P., Dubernard, JM.[2022]

Collecting qualitative data on the subjective quality of life outcomes for hand transplant recipients is essential for understanding their experiences and improving treatment approaches.

Standardizing data collection across multiple centers and using this data to create evidence-based protocols can enhance candidate evaluation and informed consent processes in hand transplantation, ensuring that patients are fully aware of their options and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Quality-of-Life Data Collection and Use Should Be Standardized When Evaluating Candidates for Hand Transplantation. Kumnig, M., Massey, EK., Parker, LS.[2020]

A review of data from over 200,000 kidney transplants indicates that the risk of developing cancer after allogeneic hand transplantation is approximately 3%, which is lower than previously reported figures.

The incidence of cataracts after 5 years post-transplantation is 11%, also lower than earlier estimates, suggesting that while immunosuppression carries risks, the actual side effects may be less severe than expected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of allogeneic hand transplantation. Baumeister, S., Kleist, C., Döhler, B., et al.[2022]

The study demonstrated that transferring four fingers and a thumb as a single allograft is anatomically feasible, with successful perfusion observed through the ulnar and radial arteries in a mock transplantation procedure.

The research highlights the importance of considering the variable anatomy of the palmar arches when planning multidigit transplantation, as the ulnar artery can supply the entire allograft but may require support from the radial artery for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cadaver Study of the Feasibility of Multidigit Allotransplantation for Reconstruction of the Metacarpal Hand. Rampazzo, A., Kutz, JE., Kaufman, C., et al.[2022]

The case study of a patient 48 months post-unilateral forearm transplantation shows no significant post-transplant infections and only a mild rejection episode, indicating a favorable safety profile for hand transplantation.

The patient achieved 53% total active motion of fingers compared to the unaffected hand and reported a significant improvement in quality of life, similar to other patients who received forearm transplants, demonstrating the efficacy of this reconstructive procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Polish forearm transplantation - final report (outcome after 4 years). Jablecki, J., Kaczmarzyk, L., Domanasiewicz, A., et al.[2021]

Hand transplantation is a complex procedure that requires a team of specialists, including surgeons, therapists, and immunologists, to ensure successful outcomes for patients.

When properly selected and managed, hand transplantation can lead to significant improvements in quality of life, but its success relies on careful patient selection, surgical technique, rehabilitation, and effective immunotherapy to prevent rejection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of hand transplantation. Shores, JT., Imbriglia, JE., Lee, WP.[2013]

Hand transplantation can fully restore hand function for upper limb amputees, but it comes with significant disadvantages and is a controversial option in the surgical community.

Prosthetic limb replacements are the standard treatment for upper limb amputees, but they have limitations in function and sensation, making the choice between transplantation and prosthetics dependent on the level and extent of the amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand Transplantation Versus Hand Prosthetics: Pros and Cons. Salminger, S., Roche, AD., Sturma, A., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Two Decades of Hand Transplantation: A Systematic Review of Outcomes. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Second report (1998-2006) of the International Registry of Hand and Composite Tissue Transplantation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Adjustment to amputation and interest in upper limb transplantation. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Hand allograft transplantation: what are the implications?]. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A Single-Center Retrospective Evaluation of Decision-Making and Factors Motivating Hand Transplant Candidates. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

World experience after more than a decade of clinical hand transplantation: update on the French program. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Why Quality-of-Life Data Collection and Use Should Be Standardized When Evaluating Candidates for Hand Transplantation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Risks of allogeneic hand transplantation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Cadaver Study of the Feasibility of Multidigit Allotransplantation for Reconstruction of the Metacarpal Hand. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

First Polish forearm transplantation - final report (outcome after 4 years). [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The current state of hand transplantation. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Hand Transplantation Versus Hand Prosthetics: Pros and Cons. [2020]