Abdominal Wall Transplantation for Abdominal Wall Defects

Overseen By Jessica Detmer-Lillard

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brigham and Women's Hospital

Disqualifiers: Psychological disorders, Cancer, Cardiac/pulmonary dysfunction, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve methods for transplanting abdominal wall tissues from deceased donors to patients with large abdominal wall defects. The goal is to develop best practices for this innovative surgery, known as Abdominal Wall Transplantation, which could significantly enhance the lives of those who haven't succeeded with other reconstructive procedures. Ideal participants have had an abdominal wall defect for over six months, are committed to extensive rehabilitation, and haven't achieved good results with standard surgeries. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this groundbreaking treatment works in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to consult with the trial coordinators for specific guidance.

What prior data suggests that abdominal wall transplantation is safe?

Research has shown that abdominal wall transplantation is generally safe for treating large abdominal wall defects. Studies have found that this procedure can effectively help close the abdomen after surgery. In one study, about 88% of the transplanted tissue survived, indicating that the surgery is often successful and complications are uncommon.

Overall, abdominal wall transplantation is considered a safe and effective option for patients with complex abdominal wall problems. While no treatment is without risk, evidence supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for abdominal wall defects, which often involve complex surgical reconstruction, abdominal wall transplantation offers a unique approach by using donor tissues to directly replace the damaged area. This method provides a more natural repair, potentially leading to better functional and cosmetic outcomes. Researchers are excited because this could transform care for patients with large defects that are difficult to manage with traditional techniques, reducing complications and improving quality of life.

What evidence suggests that abdominal wall transplantation could be an effective treatment for abdominal wall defects?

Research has shown that abdominal wall transplantation, which participants in this trial will receive, is a promising option for individuals with large abdominal wall defects. Studies have found that this procedure effectively closes large abdominal openings, particularly after complex surgeries such as intestinal transplants. The procedure transfers tissue from a deceased donor to the patient, aiding recovery and enhancing quality of life. Although this treatment is new and innovative, early reports suggest it is both safe and effective. This transplantation could significantly improve outcomes for those facing major abdominal wall issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Bohdan Pomahac, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with large abdominal wall defects who haven't had success with standard treatments. They must be motivated for a transplant and commit to two years of rehab, have had the defect for 6 months to 15 years, and normal liver/kidney function.

Inclusion Criteria

I am highly motivated to undergo a transplant.

I am committed to a 2-year rehabilitation program after my transplant.

My liver and kidney tests are normal.

Exclusion Criteria

My cancer is active, it may or may not have spread.

My kidney or liver is not working properly.

I do not have severe heart, lung, or other irreversible diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Several months

Multiple visits (in-person)

Transplantation

Transplantation of abdominal wall tissues from a deceased donor to a recipient with a large abdominal wall defect

Surgery and immediate recovery

Hospital stay

Rehabilitation

Extensive rehabilitation to provide mobility and a more natural aesthetic appearance

Several months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after transplantation

5 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal Wall Transplantation
• Immunosuppressive Agents

Trial Overview The study tests abdominal wall transplantation from deceased donors in patients with significant defects, alongside immunosuppressive drugs to prevent rejection. It aims to establish best practices for this innovative procedure.

How Is the Trial Designed?

Group I: Transplant recipients Experimental Treatment 2 Interventions

The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.

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

Approved in European Union as Abdominal Wall Transplantation for:

• Large abdominal wall defects due to multiple previous surgeries
• Extensive enterocutaneous fistulae
• Abdominal wall fibrosis and scarring
• Resection of the abdominal wall due to tumor involvement

Approved in United States as Abdominal Wall Transplantation for:

• Abdominal wall defects resulting from intestinal transplantation
• Short bowel syndrome
• Massive herniation when no other techniques are possible

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

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) 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]

Abdominal wall allotransplantation has been successfully performed in 33 patients without increasing the risk of complications or rejection of concurrent visceral organ transplants, indicating its safety as a supplementary procedure.

The transplanted abdominal wall can serve as an early indicator of rejection, potentially allowing for quicker diagnosis and intervention before symptoms appear in the bowel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal wall allotransplantation. Molitor, M., Oliverius, M., Sukop, A.[2019]

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]

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]

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. 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 ...

2. 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 ...

3. 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.

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

Abdominal Wall Transplantation: Indications and Outcomes Summary Published data suggests that abdominal wall transplantation is an effective safe solution to achieve primary closure of the abdomen ...

5. researchgate.net researchgate.net/publication/357054704_Abdominal_Wall_Vascularized_Composite_Allotransplantation_A_Scoping_Review

Abdominal Wall Vascularized Composite Allotransplantation This study aims to present a scoping review looking at all available evidence-based medicine information to understand the most current surgical techniques and ...

6. 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 ...

7. withpower.com withpower.com/trial/early-phase-1-2-2015-a8581

Abdominal Wall Transplantation for Abdominal Wall Defects Abdominal wall vascularized composite allotransplantation (AW-VCA) has been shown to be technically feasible with an overall flap/graft survival rate of 88% and ...