RECRUITING

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Conditions

Limb Amputation Extremity Amputation limb transplantation limb allotransplantation hand transplantation hand allotransplantation hand amputation leg transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Quick Facts

Study Start:2010-02-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01293214

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-02-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2010-02-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

limb transplantation
limb allotransplantation
hand transplantation
hand allotransplantation
hand amputation
leg transplantation

Additional Relevant MeSH Terms

Limb Amputation
Extremity Amputation