Abdominal Wall Transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03310905|
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : April 7, 2020
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
|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
- Number of subjects with a viable abdominal wall transplant at 18 months [ Time Frame: up to 18 months ]
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
|Contact: Linda Cendales, MDemail@example.com|
|Contact: Kadiyala Ravindra, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Linda Cendales, MD||Duke University|
|Principal Investigator:||Kadiyala Ravindra, MD||Duke University|