Recruiting
Early Phase 1

Vascularized Composite Allotransplantation

Sponsor:

Brigham and Women's Hospital

Code:

NCT02416674

Conditions

Abdominal Wall Defect

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

abdominal wall transplantation

Immunosuppressive Agents

Study Details

Brief summary:

Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.

Conditions

Abdominal Wall Defect

Study ID

NCT02416674

Start date

Mar 1, 2015

Status verified date

Jul, 2023

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Abdominal wall defects as described above
  • Strong motivation to proceed with transplantation
  • Accepts dedicating at least 2 years towards extensive post transplant rehabilitation
  • Age between 18 and 60 years
  • Elapsed injury-to-transplant time of more than 6 months and less than 15 years
  • Reports sub-optimal outcome with conventional reconstructive procedures
  • Normal liver and kidney function tests:

Exclusion Criteria:

  • Record of poor compliance
  • Unable to receive adequate follow-up care
  • Unable to receive immune suppression either due to geographic or financial limitations
  • Unable to follow strict rehabilitation schedule.
  • Documented psychological disorder(s) or incomplete psychological clearance
  • Impaired renal or hepatic function
  • Active cancer with or without metastases
  • Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable disease

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transplant recipients

The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.

Interventions

abdominal wall transplantation

transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.

Immunosuppressive Agents

Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.

Primary outcome measure

  • allograft survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jessica Detmer-Lillard

6177327874

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ashley Tremblay

617-732-7796atremblay1@bwh.harvard.edu

Elaine Devine, LSW

617-732-6967edevine2@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Keywords

  • abdominal wall
  • vascularized composite allotransplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-07-27.