Transplanting abdominal wall tissues to treat defects
Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
This study is testing if transplanting abdominal wall tissues from donors can help people with serious abdominal wall defects recover better and manage rejection after surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02416674 on ClinicalTrials.gov |
What this trial studies
This study focuses on abdominal wall transplantation, where tissues from a deceased donor are transferred to patients with significant abdominal wall defects. The research aims to establish best practices for this innovative reconstructive procedure, which includes the transplantation of skin, muscles, and blood vessels. The team at Brigham and Women's Hospital will evaluate how to enhance transplant outcomes and manage rejection issues, while also assessing the long-term recovery of recipients. Participants will need to commit to extensive rehabilitation and immunosuppressive therapy post-transplant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with significant abdominal wall defects who have not achieved satisfactory results from conventional reconstruction methods.
Not a fit: Patients with severe comorbidities, poor compliance history, or those unable to follow post-operative care protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could dramatically improve the quality of life for patients with large abdominal wall defects.
How similar studies have performed: While abdominal wall transplantation is a novel approach, similar reconstructive techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Bohdan Pomahac, MD — Brigham and Women's Hospital
- Study coordinator: Jessica Detmer-Lillard
- Phone: 6177327874
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.