Recruiting

Vascularized Composite Allotransplantation

Sponsor:

Brigham and Women's Hospital

Code:

NCT01293214

Conditions

Limb Amputation

Extremity Amputation

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Limb transplantation

Study Details

Brief summary:

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 ID

NCT01293214

Start date

Feb 1, 2010

Status verified date

Aug, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transplantation

Subjects will undergo single or multiple limb transplantation

Interventions

Limb transplantation

Primary outcome measure

  • Outcomes of limb transplantation [ Time Frame: Subjects will be followed for 18 months after transplantation ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Simon Talbot

617-732-4288sgtalbot@bwh.harvard.edu

Principal Investigator:

Simon Talbot, M.D.

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 5, 2025

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-02-05.