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

  Hide Detailed Description

Detailed Description:

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

Hand transplantation is similar to face transplantation in that the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The hand 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 hand transplantation.

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

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

We describe hand 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 hand 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 an upper extremity (upper arm, forearm and hand). However, replacing upper extremities (in whole or in part) with prosthetics remains suboptimal in that prostheses do not provide sensation and do not have a natural appearance. Hand transplant surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, hand transplant surgery can provide a patient with new hands 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 hand(s) can lead to tremendous psychological benefits, including elevated confidence and mood.

From the time we begin our search for a qualified hand 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. Hand 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.

When a donor is found, we will immediately inform the patient about when to arrive at the hospital for the operation. As the timing for this type of procedure is extremely important, patients are expected to be readily available, that is, to reside within a 12-hour travel radius of BWH. During the surgery, the parts most likely to be reconstructed include the hand and partial forearm, and in some cases, if necessary, the elbow and arm below the shoulder joint. One surgical team will work on removing the hand from the donor as another team simultaneously prepares the arm on the recipient. Surgeons will then connect the donor hand's blood vessels to the patient's blood vessels under a microscope to restore blood circulation before connecting nerves and other tissue, such as bone, cartilage and muscles, as needed.

Immediately after surgery, the hand transplant recipient will be taken to the Intensive Care Unit (ICU) for observation. The patient will typically stay in the ICU for one or two days and then be moved to a private room. At this point, a physical therapist will start working with the patient to rehabilitate the transplanted hand, and a psychiatrist will discuss any psychological concerns. The patient will stay in the hospital until both the plastic surgery and medical transplant teams agree that it is safe for the patient to return home. This post-operative stay is anticipated to be approximately 7-14 days, but can vary due to a number of factors. Rehabilitation with the physical therapist will take several hours a day while the hand transplant recipient is at the hospital.

Following discharge from the hospital, hand transplant patients will need to return to BWH for routine visits. These visits will include monitoring transplant drug levels (immune suppressants) through regular blood tests, rehabilitative therapy, imaging tests, assessing quality of life, and checking for the return of sensation and movement to the hand. Rehabilitation visits will take place daily for several months, whereas the other visits will typically take place on a weekly basis for the first three months and then at least once a month for the first year following surgery.

After the first year, it is expected that hand transplant patients will need to visit the hospital less frequently. However, patients must be prepared to make a lifetime commitment to immune suppressants to help prevent the rejection of the transplanted hand.

  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 17, 2014