Hand Transplantation for Treatment of Dominant Hand or Bilateral Hand Amputees

This study is currently recruiting participants.
Verified May 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01293214
First received: February 9, 2011
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

Hand transplantation surgery is the transfer of one or both hands from a deceased human donor to a patient with single dominant hand or bilateral hand 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 hand transplantation that will improve the outcomes of future hand transplant recipients.


Condition Intervention
Upper Extremity Amputation
Hand Amputation
Procedure: Hand transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Allograft Upper Extremity(Ies) for Treatment of Dominant Hand or Bilateral Amputees

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Outcomes of hand transplantation [ Time Frame: Subjects will be followed for 18 months after hand transplantation ] [ Designated as safety issue: No ]
    We will undertake an objective evaluation of the results of hand transplantation in an "outcome-oriented" study


Secondary Outcome Measures:
  • Efficacy and optimization of the immune suppression protocol [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.

  • Procedural outcomes of hand transplantation [ Time Frame: From subject recruitment to 18 months after transplantation ] [ Designated as safety issue: No ]
    We will optimize the screening, pre-operative, peri-operative and follow-up procedures of hand transplantation

  • Functional outcomes of hand transplantation [ Time Frame: Subjects will be followed for 18 months following hand transplantation ] [ Designated as safety issue: No ]
    We will evaluate the return of sensation and function after hand transplantation. We will use a variety of standardized tests to evaluate hand function.

  • Psychosocial outcomes of hand transplantation [ Time Frame: Subjects will be followed up for 18 months following hand transplantation ] [ Designated as safety issue: No ]
    We will evaluate the psychological and social outcomes of hand transplantation by evaluating the subject's quality of life at various time points before and after transplantation.

  • Financial and economic aspects of hand transplantation [ Time Frame: Subjects will be followed for 18 months after hand transplantation ] [ Designated as safety issue: No ]
    We will evaluate the cost-effectiveness of hand transplantation.


Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hand transplantation
Subjects will undergo single dominant hand or bilateral hand transplantation
Procedure: Hand transplantation
Hand transplantation surgery is the transfer of one or both hands from a deceased donor to a single dominant hand or bilateral hand amputee. The transplanted hand(s) may include forearm and upper arm, all the way to below the shoulder joint as needed.
Other Names:
  • upper extremity allotransplantation
  • upper extremity transplantation
  • hand allotransplantation
  • composite tissue allotransplantation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years.
  • Single dominant hand or bilateral hand amputation.
  • Time elapsed since amputation more than 6 months but less than 15 years.
  • Patient has tried myoelectric prosthesis without success.
  • Level of amputation anywhere from the wrist joint to just below the shoulder 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 hand transplant surgery or life-long immune suppression.
  • Inability to ensure adequate follow-up of post-transplant care and immune suppression.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293214

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Quinn    617-732-5303    lquinn1@partners.org   
Principal Investigator: Bohdan Pomahac, M.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Bodhan Pomahac, Medical Director, Burn Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01293214     History of Changes
Other Study ID Numbers: 2009P001719
Study First Received: February 9, 2011
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
hand transplantation
hand allotransplantation
upper extremity transplantation
upper extremity allotransplantation
upper extremity amputation
hand amputation

ClinicalTrials.gov processed this record on April 20, 2014