Abdominal Wall Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2028-06-01

Brief Summary

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The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

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Detailed Description

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Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months.

Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.

Conditions

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Transplant;Failure,Kidney Transplant; Failure, Liver Transplant; Failure, Bowel Abdominal Wall Defect Abdominal Wall Fistula Abdominal Wall Hernia Abdominal Wall Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isolated Abdominal Wall Transplant

Group Type EXPERIMENTAL

Abdominal Wall Transplant alone

Intervention Type PROCEDURE

Abdominal Wall Transplant alone

Abdominal Wall with Solid Organ Transplant

Group Type EXPERIMENTAL

Abdominal Wall Transplant with another solid organ transplant

Intervention Type PROCEDURE

Transplant of abdominal wall in combination with another solid organ transplant.

Interventions

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Abdominal Wall Transplant with another solid organ transplant

Transplant of abdominal wall in combination with another solid organ transplant.

Intervention Type PROCEDURE

Abdominal Wall Transplant alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Candidates between 18-65 years old
* Willingness and legal ability to give consent
* Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke

Exclusion Criteria

* Malignancy at evaluation or history of malignancy that precludes transplantation
* Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.
* Ongoing substance abuse or history of untreated substance abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No