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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. 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 recipients.

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 data supports the idea that Abdominal Wall Transplantation for Abdominal Wall Defects is an effective treatment?

The available research shows that Abdominal Wall Transplantation has been successfully performed in 21 patients who needed immediate abdominal closure after receiving organ transplants. This suggests that the treatment can effectively close large abdominal wall defects when other methods fail. However, there are challenges, such as the risk of rejection and complications from the drugs used to prevent rejection, as seen in a case where a patient developed a brain infection. Despite these challenges, the treatment is considered technically feasible and has been used in combination with other organ transplants to achieve successful outcomes. ^{1 2 3 4 5}

What safety data is available for abdominal wall transplantation?

Abdominal wall vascularized composite allotransplantation (AW-VCA) is a novel and technically feasible option for reconstructing large abdominal wall defects. Safety data from various studies indicate that while the procedure can be successful, it poses challenges such as graft ischemia and rejection episodes. In a 1-year follow-up study, a patient experienced three rejection episodes treated with high-dose steroids and Thymoglobulin, and developed an opportunistic fungal brain abscess due to immunosuppression. Future improvements in surgical techniques and immunosuppression regimens are suggested to enhance safety and outcomes. ^{1 2 3 4 5}

Is abdominal wall transplantation a promising treatment for abdominal wall defects?

Yes, abdominal wall transplantation is a promising treatment for abdominal wall defects. It offers a way to close large abdominal wounds when traditional methods don't work. This treatment has been successfully used in patients who also need organ transplants, helping them recover better by providing immediate closure of the abdomen. It doesn't increase the risk of complications or organ rejection and can even help detect early signs of rejection. Overall, it shows potential for improving patient outcomes. ^{1 2 3 4 6}

Research Team

Bohdan Pomahac, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgical Techniques for Revascularization in Abdominal Wall Transplantation. [2022]

2. United States 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. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Current concepts and systematic review of vascularized composite allotransplantation of the abdominal wall. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Abdominal Wall Vascularized Composite Allotransplantation: A Scoping Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Synchronous Abdominal Wall and Small-bowel Transplantation: A 1-year Follow-up. [2020]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

Abdominal wall allotransplantation. [2019]