UnknownEarly Phase 1

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

United States10 participantsStarted 2015-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

allograft survival

Timeframe: 5 years

Trial details

NCT IDNCT02416674

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Jessica Detmer-Lillard

6177327874

View on ClinicalTrials.gov More Abdominal Wall Defect trials