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Limb Transplantation for Amputation

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Must be taking: Immunosuppressants

Disqualifiers: Active malignancy, Mental instability, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor to a patient with single or multiple limb amputation. Hand transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of hand amputees. The purpose of this study is to develop the best practices for multiple limb transplantation that will improve the outcomes of future limb transplant recipients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be willing to take immunosuppressants for life, which might interact with other medications. It's best to discuss your current medications with the trial team.

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

Vascularized composite allotransplantation (VCA), which includes limb transplantation, is considered an established procedure for restoring function in patients with severe limb loss, especially when other reconstructive options are not viable. It has been successfully used for upper limb reconstruction in patients with significant tissue and functional deficits.¹ ² ³ ⁴ ⁵

Is limb transplantation generally safe for humans?

Limb transplantation, also known as vascularized composite allotransplantation (VCA), has shown good functional outcomes but comes with risks such as skin rejection and the need for long-term immunosuppression (medication to prevent the body from rejecting the transplant). Complications and failures have been reported, and the procedure is still considered complex and relatively new, with ongoing research to improve safety and outcomes.² ⁶ ⁷ ⁸ ⁹

How is limb transplantation different from other treatments for amputation?

Limb transplantation, also known as vascularized composite allotransplantation (VCA), is unique because it involves transplanting a whole limb, including skin, muscle, and bone, from a donor, unlike prosthetics which are artificial replacements. This treatment is particularly considered for patients who have lost limbs due to severe conditions like trauma or sepsis, where traditional reconstructive options are not viable.¹ ² ³ ⁴ ⁶

Research Team

Eligibility Criteria

This trial is for adults aged 18-60 who have lost one or more limbs, from the wrist/ankle to just below the shoulder/hip, and haven't had success with prosthetics. They must be willing to undergo psychological evaluation, vaccinations, take lifelong immunosuppressants, commit to a minimum of two years of rehab post-transplant, and attend follow-up visits. Not eligible if they have active cancer risks or mental instability that affects treatment compliance.

Inclusion Criteria

I am willing to take drugs for life to prevent transplant rejection.

Willing to return for follow-up visits as determined by the treating physician.

My amputation is between my wrist and shoulder or ankle and hip, and it's functional.

See 8 more

Exclusion Criteria

I currently have cancer.

I have a condition that makes surgery or long-term immune suppression risky.

My cancer is at high risk of coming back.

See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Several months

Multiple visits for psychiatric, social support evaluation, and imaging tests

Transplantation

Subjects will undergo single or multiple limb transplantation

Surgery and immediate recovery period

Inpatient hospital stay for surgery and initial recovery

Follow-up

Participants are monitored for safety and effectiveness after transplantation

18 months

Regular follow-up visits for monitoring and evaluation

Immune Suppression Optimization

Evaluation of the immune suppression protocol to prevent rejection

18 months

Treatment Details

Interventions

Limb Transplantation (Vascularized Composite Allotransplantation)

Trial OverviewThe study is testing limb transplantation from deceased donors to patients with amputations. It aims to develop best practices for this procedure in order to improve outcomes for those receiving multiple limb transplants.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TransplantationExperimental Treatment1 Intervention

Subjects will undergo single or multiple limb transplantation

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

🇺🇸 Approved in United States as Vascularized Composite Allotransplantation (VCA) for:

Multiple extremity amputations
Severe tissue defects
Complex tissue injuries

🇪🇺 Approved in European Union as Vascularized Composite Allotransplantation (VCA) for:

Severe tissue defects
Complex tissue injuries
Facial reconstruction

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Brigham and Women's HospitalBoston, MA

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Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1694

Patients Recruited

14,790,000+

Findings from Research

From July 3, 2014, to February 28, 2018, 54 candidates were added to the OPTN VCA waiting list, with a notable increase in registrations following the introduction of uterine and penile transplants in the U.S.

Out of the candidates, 22 received deceased donor VCA transplants, but waiting times varied significantly, with some candidates receiving transplants quickly while others waited over 3 years, highlighting the need for further research into access and demand in VCA transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OPTN Vascularized Composite Allograft Waiting List: Current Status and Trends in the United States.Wainright, JL., Wholley, CL., Cherikh, WS., et al.[2019]

Vascularized composite allotransplantation (VCA) involves complex transplants like hands and faces, and requires thorough psychosocial evaluations to ensure patient stability and support, as these factors significantly impact outcomes.

There is a need for standardized assessment tools to evaluate psychiatric health, social support, and quality of life in VCA patients, as nonadherence and psychosocial issues can lead to graft loss or decreased function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing psychosocial assessment for vascularized composite allotransplantation.Jowsey-Gregoire, S., Kumnig, M.[2018]

Vascularized composite allotransplantation (VCA) is an effective procedure for restoring upper limb function in patients with acquired limb loss, particularly those who have undergone amputation due to trauma or severe sepsis.

Patients with amputations resulting from sepsis face unique challenges due to their history of global tissue hypoperfusion and multisystem organ failure, which must be considered when evaluating their candidacy for VCA and other transplant procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nuances of Hand Transplantation After Sepsis.Zuo, KJ., Leonard, DA., Shores, JT., et al.[2023]

In a systematic review of 115 patients who underwent vascularized composite allotransplantation (VCA) for face and upper extremity reconstruction, the overall surgical complication rate was found to be 23%, highlighting the significant risks associated with this procedure.

The study revealed that 89% of patients experienced acute rejection, and 58% had opportunistic infections, indicating that while VCA can be beneficial for severe tissue loss, it carries a high risk of complications that must be carefully considered during patient selection and consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Reported Complications Related to Facial and Upper Extremity Vascularized Composite Allotransplantation.Milek, D., Reed, LT., Echternacht, SR., et al.[2023]

Vascularized composite allograft (VCA) transplants involve multiple tissues and are becoming more common, but there is limited data on their graft survival and infection risks.

VCA transplants have unique infection risk factors that differ from those associated with solid organ transplants, highlighting the need for tailored management strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious complications of vascularized composite allograft transplantation.Steinbrink, JM., Wolfe, CR.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-induced Rejection in Vascularized Composite Allotransplantation.Etra, JW., Shores, JT., Sander, IB., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized Composite Allotransplantation: Medical Complications.Uluer, MC., Brazio, PS., Woodall, JD., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative risk factors for vascularized composite allotransplantation: a systematic review and proposal of identity-defining VCA.Zhu, H., Wei, X., Lineaweaver, W., et al.[2022]

Vascularized composite allotransplantation (VCA) is an innovative treatment for patients with limb loss or severe facial disfigurement, with 72 hand and 19 facial transplants performed globally.

While VCA can lead to good functional outcomes, it is complicated by skin rejection and requires long-term immunosuppression, highlighting the need for strategies to minimize immunosuppressive therapy to reduce associated risks and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial and hand allotransplantation.Pomahac, B., Gobble, RM., Schneeberger, S.[2022]