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NCT03310905 Clinical Trial

Abdominal Wall Transplant

Transplant;Failure,Kidney Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03310905
Other study ID # Pro00084054
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date June 1, 2028

Study information
Verified date January 2024
Source Duke University
Contact Linda Cendales, MD
Phone 919-681-7514
Email linda.cendales@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5
Est. completion date June 1, 2028
Est. primary completion date January 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Abdominal Wall Transplant with another solid organ transplant
Transplant of abdominal wall in combination with another solid organ transplant.
• Abdominal Wall Transplant alone
Abdominal Wall Transplant alone

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (4)
Lead Sponsor Collaborator
Duke University Detlev Erdmann, M.D., Kadiyala Ravindra, M.D., Linda Cendales, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects with a viable abdominal wall transplant at 18 months up to 18 months
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