Abdominal Wall Transplant for Abdominal Wall Defects

Overseen By Linda Cendales, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Malignancy, Pregnancy, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an abdominal wall transplant can safely and effectively repair abdominal wall defects. It will test two approaches: a transplant of only the abdominal wall and a transplant of the abdominal wall combined with another organ. Suitable candidates have serious abdominal wall issues and qualify for an organ transplant. The research aims to determine if these transplants can successfully repair and restore function to damaged abdominal walls. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research that could lead to innovative treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for abdominal wall transplantation?

Research has shown that abdominal wall transplantation is a safe option for addressing large and complex abdominal wall problems. Studies have found that this procedure can successfully close the abdomen after other transplants, such as intestinal transplants, without adding extra risks. Recent evidence suggests that combining an abdominal wall transplant with an intestinal transplant does not increase risk. Overall, findings indicate that the procedure is well-tolerated and promising for patients requiring this type of surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for abdominal wall defects, which typically involve surgical repair using synthetic meshes or autologous tissue flaps, the abdominal wall transplant offers a novel approach by replacing the damaged abdominal wall with a healthy one from a donor. Researchers are excited about this treatment because it has the potential to provide a more durable and functional solution, especially for patients with complex defects that are difficult to repair with traditional methods. Additionally, the option to combine an abdominal wall transplant with a solid organ transplant could significantly improve outcomes for patients needing multiple transplants, offering a comprehensive solution in a single procedure.

What evidence suggests that abdominal wall transplantation is effective for abdominal wall defects?

Research has shown that abdominal wall transplantation is a safe and effective method for addressing large or complex abdominal wall problems. In this trial, participants may receive either an isolated abdominal wall transplant or one combined with a solid organ transplant. Studies indicate that abdominal wall transplantation is particularly effective when performed alongside other organ transplants, such as intestinal transplants, without increasing risk. Patients who have received this treatment have experienced positive outcomes, making it a promising option for those with challenging abdominal wall issues. Overall, this treatment has successfully helped patients recover from major abdominal wall problems. ^{1 3 4 6 7}

Who Is on the Research Team?

Kadiyala Ravindra, MD

Principal Investigator

Duke University

Linda Cendales, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with severe abdominal wall defects, possibly needing an additional organ transplant. Candidates must be able to consent and meet criteria for a non-vascularized composite allograft at Duke. Exclusions include cancer history, pregnancy or potential pregnancy without agreed contraception use, anesthesia risks, and untreated substance abuse.

Inclusion Criteria

I am eligible for an organ transplant at Duke, including my abdominal wall.

I am willing and legally able to consent to participate.

Exclusion Criteria

You are currently using drugs or have a history of using drugs without getting help.

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.

My cancer or past cancer prevents me from having a transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Initial Treatment

Participants undergo abdominal wall transplantation, either alone or in combination with another organ transplant, and receive standard immunosuppression therapy

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness of the abdominal wall transplant to restore function of the defective abdominal wall

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal Wall Transplant
• Immunosuppressive Agents

Trial Overview The study is testing the safety and effectiveness of abdominal wall transplants either as a standalone procedure or alongside another solid organ transplant. The goal is to see how well this surgery repairs serious abdominal wall problems.

How Is the Trial Designed?

Group I: Isolated Abdominal Wall Transplant Experimental Treatment 1 Intervention

Group II: Abdominal Wall with Solid Organ Transplant Experimental Treatment 1 Intervention

Abdominal Wall Transplant is already approved in European Union, United States for the following indications:

Approved in European Union as Abdominal Wall Transplantation for:

• Reconstruction of abdominal wall defects after intestinal transplantation
• Reconstruction of abdominal wall defects after multivisceral transplantation

Approved in United States as Abdominal Wall Transplantation for:

• Reconstruction of abdominal wall defects after intestinal transplantation
• Reconstruction of abdominal wall defects after multivisceral transplantation

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Linda Cendales

Lead Sponsor

Trials

2

Recruited

60+

Linda Cendales, MD

Collaborator

Trials

1

Recruited

5+

Detlev Erdmann, M.D.

Collaborator

Trials

1

Recruited

5+

Kadiyala Ravindra, M.D.

Collaborator

Trials

1

Recruited

5+

Published Research Related to This Trial

Abdominal wall vascularized composite allotransplantation (AW-VCA) has been shown to be technically feasible with an overall flap/graft survival rate of 88% and no reported mortality related to the transplant, based on a systematic review of 18 procedures performed in 17 patients.

The study highlights that while AW-VCA presents low morbidity and mortality, functional outcomes were not adequately reported, indicating a need for further research to assess the long-term benefits and applications of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts and systematic review of vascularized composite allotransplantation of the abdominal wall. Berli, JU., Broyles, JM., Lough, D., et al.[2022]

This study successfully established a novel anatomical model for abdominal wall vascularized composite allotransplantation (AW-VCA) using fresh cadaver torsos, demonstrating the feasibility of preserving motor and sensory functions in abdominal wall reconstruction.

The mean size of the harvested abdominal wall graft was 615 cm², and the identification of thoracolumbar nerves suggests that this approach could allow for functional recovery, potentially improving outcomes in patients with large abdominal wall defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional abdominal wall reconstruction using an innervated abdominal wall vascularized composite tissue allograft: a cadaveric study and review of the literature. Broyles, JM., Berli, J., Tuffaha, SH., et al.[2022]

The first synchronous child-to-adult abdominal wall-vascularized composite allotransplantation (AW-VCA) was successfully performed, demonstrating the feasibility of this complex surgical option for patients with severe abdominal wall reconstruction needs.

The patient experienced three episodes of rejection, which were managed with high-dose steroids and Thymoglobulin, but also developed a fungal brain abscess due to immunosuppression, highlighting the risks associated with such treatments and the need for improved immunosuppression strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synchronous Abdominal Wall and Small-bowel Transplantation: A 1-year Follow-up. Atia, A., Hollins, A., Erdmann, RF., et al.[2020]

Abdominal wall transplantation is a viable option for patients undergoing intestinal transplants, with 15 procedures performed on 14 patients, demonstrating its feasibility when primary closure is not possible.

While there were some complications, including two graft losses due to vascular thrombosis and three episodes of rejection treatable with steroids, the majority of patients survived, indicating that this technique can be safely integrated into complex transplant surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal wall transplantation: surgical and immunologic aspects. Selvaggi, G., Levi, DM., Cipriani, R., et al.[2022]

Abdominal wall vascularized composite allotransplantation (AW-VCA) is a promising option for reconstructing the abdominal wall in patients who cannot undergo traditional closure methods, with various revascularization techniques reported in the literature.

Four distinct revascularization techniques were identified, including methods that reduce graft ischemia time and improve surgical outcomes, highlighting the importance of optimizing these techniques as the field of AW-VCA evolves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Techniques for Revascularization in Abdominal Wall Transplantation. Atia, A., Hollins, A., Shammas, R., et al.[2022]

Abdominal wall vascularized composite allotransplantation (AW-VCA) is a promising and safe reconstructive technique for patients with large abdominal wall defects, showing high flap survival rates and low complication rates across various surgical methods.

The use of iliofemoral cuff-based flaps in cadaveric studies ensures good tissue perfusion, while incorporating thoracolumbar nerves can enhance functionality and prevent muscle atrophy in AW-VCA, indicating a potential for improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal Wall Vascularized Composite Allotransplantation: A Scoping Review. Bustos, VP., Escandón, JM., Santamaría, E., et al.[2022]

Citations

1. link.springer.com link.springer.com/article/10.1007/s40472-020-00308-9

Abdominal Wall Transplantation: Indications and Outcomes Abdominal wall transplantation is an effective safe solution to achieve primary closure of the abdomen after intestinal or multivisceral transplant.

2. research.rug.nl research.rug.nl/files/178364476/Honeyman2020_Article_AbdominalWallTransplantationIn.pdf

Abdominal Wall Transplantation: Indications and Outcomes Recent evidence suggests that combining a skin containing abdominal wall transplant with an intestinal transplant does not appear to increase.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34905782/

Abdominal Wall Vascularized Composite Allotransplantation AW-VCA is a safe and efficient alternative for patients with large and complex abdominal wall defects. The future holds a promising ...

4. d-nb.info d-nb.info/1225625858/34

Abdominal Wall Transplantation: Indications and Outcomes Recent evidence suggests that combining a skin containing abdominal wall transplant with an intestinal transplant does not appear to increase.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955470X21000409

Allotransplantation of donor rectus fascia for abdominal ... This systematic literature review reports two emerging new techniques for complex abdominal wall closure in transplant patients, with promising results.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02416674

Vascularized Composite Allotransplantation for Treatment ... 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 ...

7. thieme-connect.com thieme-connect.com/products/ejournals/pdf/10.1055/s-0041-1740121.pdf

Abdominal Wall Vascularized Composite Allotransplantation Conclusion AW-VCA is a safe and efficient alternative for patients with large and complex abdominal wall defects. The future holds a promising ...