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RECRUITING Not applicable ClinicalTrials.gov

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Sponsor: Brigham and Women's Hospital • ClinicalTrials.gov ID: NCT01293214

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Limb transplantation (Procedure)

Eligibility criteria

Inclusion Criteria: * Age between 18 and 60 years. * Single dominant hand or multiple limb amputation. * Time elapsed since amputation more than 6 months but less than 15 years. * Patient has tried prosthesis without success. * Level of amputation anywhere from the wrist (or ankle) joint to just below the shoulder (or hip) joint, which should be functional. * Signed written informed consent. * Willing to complete psychological and social evaluations. * Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life. * Willing to comply with extensive post-transplant rehabilitation for a minimum of two years. * Willing to return for follow-up visits as determined by the treating physician. * Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B. Exclusion Criteria: * Single, non-dominant hand amputees. * Active malignancy. * High risk of return of malignancy. * History of persistent non-compliance. * Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability. * Any diagnosis that puts the subject at risk from limb transplant surgery or life-long immune suppression. * Inability to ensure adequate follow-up of post-transplant care and immune suppression.

Conditions

Limb Amputation Extremity Amputation

Locations

  • Brigham and Women's Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record