Abdominal Wall Transplant

Sponsor

Linda Cendales (Other)

Overall Status

Recruiting

CT.gov ID

NCT03310905

Collaborator

Linda Cendales, MD (Other), Kadiyala Ravindra, M.D. (Other), Detlev Erdmann, M.D. (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Transplant;Failure,Kidney Transplant; Failure, Liver Transplant; Failure, Bowel Abdominal Wall Defect Abdominal Wall Fistula Abdominal Wall Hernia Abdominal Wall Injury	Drug: Immunosuppressive Agents Procedure: Abdominal Wall Transplant	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isolated Abdominal Wall Transplant	Drug: Immunosuppressive Agents Standard immunosuppression therapy following an isolated abdominal wall transplant. Other Names: Abdominal Wall in VCA
Experimental: Abdominal Wall with Solid Organ Transplant	Procedure: Abdominal Wall Transplant Transplant of abdominal wall alone or in combination with another solid organ transplant. Other Names: Abdominal Wall with another solid organ transplant

Arm

Intervention/Treatment

Experimental: Isolated Abdominal Wall Transplant

Drug: Immunosuppressive Agents

Standard immunosuppression therapy following an isolated abdominal wall transplant.

Other Names:

Abdominal Wall in VCA

Experimental: Abdominal Wall with Solid Organ Transplant

Procedure: Abdominal Wall Transplant

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

Other Names:

Abdominal Wall with another solid organ transplant

Outcome Measures

Primary Outcome Measures

Number of subjects with a viable abdominal wall transplant at 18 months [up to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Medical exclusion criteria for general anesthesia
Ongoing substance abuse or history of untreated substance abuse