Vascularized Composite Allotransplantation for Multiple Extremity Amputations

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Limb Amputation
Extremity Amputation
Procedure: Limb transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascularized Composite Allotransplantation for Multiple Extremity Amputations

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

Primary Outcome Measures:
  • Outcomes of limb transplantation [ Time Frame: Subjects will be followed for 18 months after transplantation ] [ Designated as safety issue: No ]
    We will undertake an objective evaluation of the results of limb 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.


Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transplantation
Subjects will undergo single or multiple limb transplantation
Procedure: Limb transplantation
Other Name: vascularized composite allotransplantation

Detailed Description:

Limb transplantation surgery, the transfer of the limb(s) from a deceased human donor to a patient with amputation of one or more limbss, is an experimental reconstructive procedure that has the potential to significantly improve the lives of amputees.

Limb transplantation is similar to face transplantation in that the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital includes a wide variety of medical and surgical specialties. The team hopes to build upon the success of their first face transplantation to provide amputee patients with the significant benefits of limb transplantation.

Toward this goal, BWH is actively seeking qualified candidates for the limb transplant research study. We will be studying a small group of people to learn more about:

  • How to advance the science of limb transplantation
  • How to support and limit transplant rejection issues
  • How people do after limb transplantation

We describe limb transplant surgery as a life-giving procedure because it has the potential to dramatically improve, that is to restore, both a patient's mental and physical health and his/her ability to function and integrate in society. However, as with any other type of organ transplantation, this improvement will require the patient to make a lifetime commitment to taking medications that suppress the body's immune system.

Conventional reconstruction methods are always considered first, but they may provide less than optimal results for certain patients. There are many sophisticated prostheses that satisfactorily replace the basic function of a missing limb. However, replacing limbs (in whole or in part) with prosthetics remains suboptimal in that prostheses do not provide sensation and do not have a natural appearance. Limbtransplant surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, limb transplant surgery can provide a patient with new limbs that, after extensive rehabilitation, allow him/her to perform daily activities and, in most cases, return to work. Furthermore, the ability to restore a near-normal aesthetic appearance of the limb(s) can lead to tremendous psychological benefits, including elevated confidence and mood.

From the time we begin our search for a qualified limb transplant recipient to the continuing care we provide following surgery, a significant amount of time, expertise and attentiveness is contributed toward making the procedure a progressive success. Limb transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, we will place the patient on a transplant waiting list. We will then begin working with the New England Organ Bank (NEOB) team to find a donor who matches the recipient's tissue requirements - for example similar age and correct blood type. This search could take many months, and, if a suitable donor is not found within one year, we will speak with the patient to determine whether he/she is willing to continue waiting.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 2009P000073
Study First Received: February 9, 2011
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
limb transplantation
limb allotransplantation
hand transplantation
hand allotransplantation
hand amputation
leg transplantation

ClinicalTrials.gov processed this record on September 18, 2014