Transplanting abdominal wall tissue to repair defects
Official title: Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
Run by Duke University · NCT03310905 · Data updated 2026-11-12
This study is testing if transplanting abdominal wall tissue can safely fix defects in the abdominal area for people who need it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 1, 2018 |
| Main results expected | January 1, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT03310905 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 who require abdominal wall reconstruction and are eligible for organ transplantation.
✕Probably not a fit
Patients with active malignancies, pregnancy, or those who do not meet the medical criteria for anesthesia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of abdominal wall transplantation for reconstructing abdominal wall defects. The study will involve five participants who will receive either an isolated abdominal wall transplant or a transplant combined with another organ. Each participant will be monitored for 18 months to assess the functionality of the transplanted tissue and the overall outcomes of the procedure. Standard immunosuppression therapy will be administered to prevent organ rejection.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with severe abdominal wall defects.
How similar studies have gone: While abdominal wall transplantation is a novel approach, similar transplant methodologies have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Linda Cendales, MD — Duke University
- Study coordinator: Linda Cendales, MD
- Email: linda.cendales@duke.edu
- Phone: 919-681-7514
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.