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Abdominal Wall Transplantation for Abdominal Wall Defects

Phase < 1
Recruiting
Led By Bohdan Pomahac, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal liver and kidney function tests
Abdominal wall defects as described above
Must not have
Active cancer with or without metastases
Impaired renal or hepatic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will help improve the outcomes of future abdominal wall transplant recipients by developing the best practices for the surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include those related to surgery such as infection or bleeding, and those due to immunosuppressive medications like increased risk of infections, possible kidney damage, high blood pressure, diabetes, and cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver and kidney tests are normal.
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I have a defect in my abdominal wall as described.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is active, it may or may not have spread.
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My kidney or liver is not working properly.
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I do not have severe heart, lung, or other irreversible diseases.
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I can't get immune suppression treatment due to location or cost issues.
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I cannot follow a strict rehabilitation schedule.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
donation of abdominal wall

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transplant recipientsExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immunosuppressive Agents
2014
N/A
~3240

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,256 Total Patients Enrolled
1 Trials studying Abdominal Wall Defects
2 Patients Enrolled for Abdominal Wall Defects
Bohdan Pomahac, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Abdominal Wall Defects
2 Patients Enrolled for Abdominal Wall Defects

Media Library

Abdominal Wall Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT02416674 — Phase < 1
Abdominal Wall Defects Research Study Groups: Transplant recipients
Abdominal Wall Defects Clinical Trial 2023: Abdominal Wall Transplantation Highlights & Side Effects. Trial Name: NCT02416674 — Phase < 1
Abdominal Wall Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT02416674 — Phase < 1
~0 spots leftby Feb 2025
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