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Abdominal Wall Transplant

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ClinicalTrials.gov Identifier: NCT03310905
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Linda Cendales, MD
Kadiyala Ravindra, M.D.
Detlev Erdmann, M.D.
Information provided by (Responsible Party):
Linda Cendales, MD, Duke University

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: Belatacept 5mg/kg IV monthly 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 transplant will be treated with immunosuppression known to prevent rejection of allografted tissues and designed to minimize exposure to calcineurin inhibitor based immunosuppression by using a drug called Belatacept. This will include monthly infusions for the 18-month study period that will take place at Duke University Medical Center.

Participants receiving an 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  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Abdominal Wall Transplant with Belatacept Drug: Belatacept 5mg/kg IV monthly
Belatacept infusions following an isolated abdominal wall transplant.
Other Name: 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 Name: Abdominal Wall with another solid organ transplant




Primary Outcome Measures :
  1. Number of subjects with a viable abdominal wall transplant at 18 months [ Time Frame: up to 18 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310905


Contacts
Contact: Linda Cendales, MD 919-681-7514 linda.cendales@duke.edu
Contact: Kadiyala Ravindra, MD 919-613-9687 kadiyala.ravindra@duke.edu

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Linda Cendales, MD
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

Responsible Party: Linda Cendales, MD, Associate Professor, Duke University
ClinicalTrials.gov Identifier: NCT03310905     History of Changes
Other Study ID Numbers: Pro00084054
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Linda Cendales, MD, Duke University:
Research
Transplant
Abdominal Wall
Hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Fistula
Renal Insufficiency
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents