Transplanting abdominal wall tissue to repair defects
Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
This study is testing if transplanting abdominal wall tissue can safely fix defects in the abdominal area for people who need it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03310905 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who require abdominal wall reconstruction and are eligible for organ transplantation.
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.
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 performed: While abdominal wall transplantation is a novel approach, similar transplant methodologies have shown promise in other studies.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.