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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a surgery called hand transplantation, which aims to improve function, appearance, and feeling in hands and forearms for individuals who have lost them due to injury. The procedure transfers tissue from a non-living donor to the recipient. The study will monitor patient recovery and outcomes through various medical evaluations. Individuals missing all or part of one or both hands and forearms, who have experienced difficulties with prosthetics, may be suitable candidates for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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 prior data suggests that this hand transplantation procedure is safe?

Research has shown that receiving a hand transplant from a deceased donor can be a safe option for individuals who have lost a hand or forearm. One study found that while the appearance of the transplanted hand might change over time, the procedure's safety largely depends on the amputation site. Another study indicated that individuals with transplanted hands generally use them more than those with artificial hands, suggesting good acceptance of the transplants.

However, careful selection of candidates is crucial, as not everyone is a suitable fit. Some reports suggest that while hand transplants can be effective, they must be tailored to each person's unique situation. Overall, despite some risks, the procedure has proven to be a safe option for many needing reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard prosthetic options for hand amputation, hand transplantation offers the potential for a fully integrated, living hand that can grow, heal, and respond to sensory input. Researchers are excited about this treatment because it can restore not just basic functionality, but also the sensation and appearance of a natural hand. This approach leverages the body's natural regenerative capabilities, making it a transformative option for those who have lost one or both hands due to traumatic injury.

What evidence suggests that hand transplantation is effective for traumatic amputation of the hand?

Research has shown that hand transplants, which participants in this trial may receive, can help people regain function and feeling in their amputated hands. Patients have experienced nerve regrowth at a rate of 2–3 millimeters per day, enhancing sensation. Studies indicate that transplant patients exhibit better hand movement and can perform daily activities more easily. For those with amputated hands, successful transplants have led to improved function and appearance, similar to reattachment after an injury. Overall, hand transplantation has the potential to greatly improve the quality of life for individuals with hand amputations. ^{2 3 6 7 8}

Who Is on the Research Team?

Sheel Sharma, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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

I have some upper arm muscles left to control a prosthetic hand.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7268554/

All hands on deck: Hand replantation versus transplantation

As in replantation, transplantation at more distal levels yielded better sensorimotor recovery, with persistent improvement beyond 2 years. In the previously ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8930848/

Hand Transplants, Daily Functioning, and the Human ...

Clinical reports have noted increased rates of nerve regeneration, up to 2–3 mm per day in hand transplant patients on immune suppressive ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589514124002329

Thirty-Eight-Year Follow-Up After Multiple Toe-to-Hand ...

A case series of 12 second toe-to-hand transplantations after traumatic finger amputations demonstrated 100% transplant survival and good sensory recovery at 6 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01459107

NCT01459107 | Human Upper Extremity Allotransplantation

Significance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into ...

5.

aetna.com

aetna.com/cpb/medical/data/800_899/0816.html

Hand Transplantation - Medical Clinical Policy Bulletins

Acceptable functional and cosmetic outcomes, particularly for bilateral amputees, have been achieved and are similar to hand replantation at equivalent levels.

6.

pmc.ncbi.nlm.nih.gov

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

Long‐term outcome after hand and forearm transplantation

In the long‐term, a change in hand appearance was observed. The functional outcome was highly depending on the level of amputation. The number and severity of ...

7.

member.myhealthtoolkitaz.com

member.myhealthtoolkitaz.com/web/public/brands/medicalpolicyhb/external-policies/composite-tissue-allotransplantation-of-the-hand-and-face/

Composite Tissue Allotransplantation of the Hand and Face

Few data on functional outcomes after hand transplantation have been reported. The authors noted that there is a lack of agreement on appropriate outcome ...

8.

cdmrp.health.mil

cdmrp.health.mil/rtrp/research_highlights/20frey_highlight

2020 Reconstructive Transplant Research Highlight

Hand transplant recipients use their affected hands more than amputees use their prostheses, but less than controls use their intact limbs.