Abdominal Wall Transplant
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | May 1, 2018 |
| End Date: | January 1, 2022 |
| Contact: | Linda Cendales, MD |
| Email: | linda.cendales@duke.edu |
| Phone: | 919-681-7514 |
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.
transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal
wall transplantation may be performed alone or in combination with another transplant.
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.
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.
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
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