Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Abdominal Wall Defect Clinical Trial

Official title:

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02416674
• Other study ID #: 2013P002556
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 1, 2015
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: Jessica Detmer-Lillard
• Phone: 6177327874
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall Defect

Intervention

Procedure:
• abdominal wall transplantation
transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.

Drug:
• Immunosuppressive Agents
Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	allograft survival		5 years
Secondary	immune rejection episodes		5 years
Secondary	infections		5 years
Secondary	donation of abdominal wall	We will investigate how families of deceased organ donors respond to the request for donation of the abdominal wall tissues	5 years