Abdominal Wall Transplant

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University; Linda Cendales
• Collaborators: Detlev Erdmann, M.D.; Kadiyala Ravindra, M.D.; Linda Cendales, MD
• Treatments: Abatacept; Immunosuppressive Agents

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