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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Wall Defect
• Abdominal Wall Fistula
• Abdominal Wall Hernia
• Abdominal Wall Injury
• Fistula
• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia
• Renal Insufficiency
• Transplant; Failure, Bowel
• Transplant; Failure, Liver
• Transplant;Failure,Kidney

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