Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

July 26, 2023 updated by: Bohdan Pomahac, Brigham and Women's Hospital
Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.

Study Overview

Detailed Description

Abdominal wall transplantation surgery, the transfer of the abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect, is an experimental reconstructive procedure that has the potential to significantly improve the lives of patients.

In abdominal wall transplantation, 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 BWH is actively seeking qualified candidates for the abdominal wall transplantation research study. We will be studying a small group of people to learn more about:

  • How to advance the science of abdominal wall transplantation
  • How to support and limit transplant rejection issues
  • How people do after abdominal wall transplantation We describe abdominal wall 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 other methods available to reconstruct the abdominal wall. However, they may yield unsatisfactory outcomes in some patients. Abdominal wall transplantation surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, abdominal wall transplant surgery can provide a patient with a new abdominal wall that, after extensive rehabilitation, will provide mobility and a more natural aesthetic appearance.

From the time we begin our search for a qualified abdominal wall 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. Abdominal wall 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 United Network for Organ Sharing 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jessica Detmer-Lillard
  • Phone Number: 6177327874

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Abdominal wall defects as described above
  • Strong motivation to proceed with transplantation
  • Accepts dedicating at least 2 years towards extensive post transplant rehabilitation
  • Age between 18 and 60 years
  • Elapsed injury-to-transplant time of more than 6 months and less than 15 years
  • Reports sub-optimal outcome with conventional reconstructive procedures
  • Normal liver and kidney function tests:

Exclusion Criteria:

  • Record of poor compliance
  • Unable to receive adequate follow-up care
  • Unable to receive immune suppression either due to geographic or financial limitations
  • Unable to follow strict rehabilitation schedule.
  • Documented psychological disorder(s) or incomplete psychological clearance
  • Impaired renal or hepatic function
  • Active cancer with or without metastases
  • Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplant recipients
The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.
transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.
Other Names:
  • vascularized composite allotransplantation
Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
allograft survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immune rejection episodes
Time Frame: 5 years
5 years
infections
Time Frame: 5 years
5 years
donation of abdominal wall
Time Frame: 5 years
We will investigate how families of deceased organ donors respond to the request for donation of the abdominal wall tissues
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bohdan Pomahac, MD, 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 Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimated)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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