Abdominal Wall Transplant

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Wall Defect; Abdominal Wall Hernia; Transplant; Failure, Liver; Transplant;Failure,Kidney; Transplant; Failure, Bowel; Abdominal Wall Fistula; Abdominal Wall Injury
• Intervention / Treatment: Procedure: Abdominal Wall Transplant alone; Procedure: Abdominal Wall Transplant with another solid organ transplant

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 Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Cendales, MD; Phone Number: 919-681-7514; Email: linda.cendales@duke.edu
• Study Contact Backup: Name: Kadiyala Ravindra, MD; Phone Number: 919-613-9687; Email: kadiyala.ravindra@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isolated Abdominal Wall Transplant	Procedure: Abdominal Wall Transplant alone; Abdominal Wall Transplant alone
Experimental: Abdominal Wall with Solid Organ Transplant	Procedure: Abdominal Wall Transplant with another solid organ transplant; Transplant of abdominal wall in combination with another solid organ transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with a viable abdominal wall transplant at 18 months	up to 18 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Linda Cendales, MD; Kadiyala Ravindra, M.D.; Detlev Erdmann, M.D.
• Investigators: Principal Investigator: Linda Cendales, MD, Duke University; Principal Investigator: Kadiyala Ravindra, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Research; Transplant; Hernia; Abdominal Wall
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hernia; Fistula; Renal Insufficiency; Hernia, Ventral; Hernia, Abdominal; Internal Hernia; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: Pro00084054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No