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Abdominal Wall Transplantation for Abdominal Wall Defects

Q: Does this experiment permit enrollment of adults over the age of eighteen?

Prospective participants in this trial must be over the age of 18, but under 60 years old.

Q: How many individuals have been inducted into this medical trial so far?

Affirmative. Clinicaltrials.gov reflects that this trial, first posted on March 1st 2015, is still looking for participants. 10 individuals are desired from a single medical site.

Q: Are there any current vacancies available for participants of this trial?

As per the findings on clinicaltrials.gov, this medical trial is presently recruiting qualified participants. The listing was initially shared online in March 2015 and has been revised as recently as January 25th 2021.

Q: Who qualifies to partake in this research trial?

Researchers are recruiting 10 participants with abdominal wall defects, aged 18-60. To be considered for the trial, prospects must have a powerful incentive to receive transplantation, commit two years of vigorous postoperative rehabilitation, have sustained their wound no earlier than 6 months and not more than 15 years ago, and report unsatisfactory results from traditional reconstructive techniques.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

allograft survival

Secondary outcome measures

donation of abdominal wall

immune rejection episodes

infections

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,470,317 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment permit enrollment of adults over the age of eighteen?

"Prospective participants in this trial must be over the age of 18, but under 60 years old."

Answered by AI

How many individuals have been inducted into this medical trial so far?

"Affirmative. Clinicaltrials.gov reflects that this trial, first posted on March 1st 2015, is still looking for participants. 10 individuals are desired from a single medical site."

Answered by AI

Are there any current vacancies available for participants of this trial?

"As per the findings on clinicaltrials.gov, this medical trial is presently recruiting qualified participants. The listing was initially shared online in March 2015 and has been revised as recently as January 25th 2021."

Answered by AI

Who qualifies to partake in this research trial?

"Researchers are recruiting 10 participants with abdominal wall defects, aged 18-60. To be considered for the trial, prospects must have a powerful incentive to receive transplantation, commit two years of vigorous postoperative rehabilitation, have sustained their wound no earlier than 6 months and not more than 15 years ago, and report unsatisfactory results from traditional reconstructive techniques."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Bohdan Pomahac 2015. "Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02416674.