Vascularized Composite Allotransplantation for Multiple Extremity Amputations

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.

Conditions

Limb Amputation, Extremity Amputation

Study Overview

Study Details

Study overview

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.

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Condition
Limb Amputation
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2025-12-31