- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02416674
Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abdominal wall transplantation surgery, the transfer of the abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect, is an experimental reconstructive procedure that has the potential to significantly improve the lives of patients.
In abdominal wall transplantation, the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital includes a wide variety of medical and surgical specialties.
The team BWH is actively seeking qualified candidates for the abdominal wall transplantation research study. We will be studying a small group of people to learn more about:
- How to advance the science of abdominal wall transplantation
- How to support and limit transplant rejection issues
- How people do after abdominal wall transplantation We describe abdominal wall transplant surgery as a life-giving procedure because it has the potential to dramatically improve, that is to restore, both a patient's mental and physical health and his/her ability to function and integrate in society. However, as with any other type of organ transplantation, this improvement will require the patient to make a lifetime commitment to taking medications that suppress the body's immune system.
Conventional reconstruction methods are always considered first, but they may provide less than optimal results for certain patients. There are other methods available to reconstruct the abdominal wall. However, they may yield unsatisfactory outcomes in some patients. Abdominal wall transplantation surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, abdominal wall transplant surgery can provide a patient with a new abdominal wall that, after extensive rehabilitation, will provide mobility and a more natural aesthetic appearance.
From the time we begin our search for a qualified abdominal wall transplant recipient to the continuing care we provide following surgery, a significant amount of time, expertise and attentiveness is contributed toward making the procedure a progressive success. Abdominal wall transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, we will place the patient on a transplant waiting list. We will then begin working with the United Network for Organ Sharing to find a donor who matches the recipient's tissue requirements - for example similar age and correct blood type. This search could take many months, and, if a suitable donor is not found within one year, we will speak with the patient to determine whether he/she is willing to continue waiting.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Jessica Detmer-Lillard
- Phone Number: 6177327874
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
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Contact:
- Ashley Tremblay
- Phone Number: 617-732-7796
- Email: atremblay1@bwh.harvard.edu
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Contact:
- Elaine Devine, LSW
- Phone Number: 617-732-6967
- Email: edevine2@bwh.harvard.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Abdominal wall defects as described above
- Strong motivation to proceed with transplantation
- Accepts dedicating at least 2 years towards extensive post transplant rehabilitation
- Age between 18 and 60 years
- Elapsed injury-to-transplant time of more than 6 months and less than 15 years
- Reports sub-optimal outcome with conventional reconstructive procedures
- Normal liver and kidney function tests:
Exclusion Criteria:
- Record of poor compliance
- Unable to receive adequate follow-up care
- Unable to receive immune suppression either due to geographic or financial limitations
- Unable to follow strict rehabilitation schedule.
- Documented psychological disorder(s) or incomplete psychological clearance
- Impaired renal or hepatic function
- Active cancer with or without metastases
- Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transplant recipients
The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.
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transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.
Other Names:
Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
allograft survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immune rejection episodes
Time Frame: 5 years
|
5 years
|
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infections
Time Frame: 5 years
|
5 years
|
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donation of abdominal wall
Time Frame: 5 years
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We will investigate how families of deceased organ donors respond to the request for donation of the abdominal wall tissues
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5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bohdan Pomahac, MD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P002556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Wall Defect
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Meccellis BiotechRecruitingAbdominal Hernia | Abdominal Wall Defect | Abdominal Wall InjuryFrance
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University of Sao Paulo General HospitalCompletedAbdominal Wall Defect | Infection | Abdominal Wall Hernia | Abdominal Wall Fistula | Abdominal Wall InfectionBrazil
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University of Sao Paulo General HospitalCompletedAbdominal Wall Defect | Infection | Abdominal Wall Fistula | Abdominal Wall InfectionBrazil
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Zagazig UniversityCompleted
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Medical University of GrazCompleted
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Henares University HospitalCompletedHernia | Abdominal Wall Defect | Incisional Hernia | Abdominal Wall HerniaSpain
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Poznan University of Medical SciencesRecruiting
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Aga Khan UniversityUnknownAbdominal Wall DefectPakistan
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University College, LondonUniversity College London HospitalsUnknownVentral Hernia | Abdominal Wall DefectUnited Kingdom
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Aesculap AGB.Braun Surgical SACompletedVentral Hernia | Abdominal Hernia | Abdominal Wall Defect | Fascial HerniaSpain
Clinical Trials on abdominal wall transplantation
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Hungarian Surgical SocietyCompletedAbdominal HerniaHungary
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The Cleveland ClinicRecruitingHernia, Abdominal | Hernia, Ventral | Hernia Abdominal WallUnited States
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University of PrimorskaFotona d.o.o.Completed
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Bursa Yüksek İhtisas Education and Research HospitalCompletedLaparoscopy | Abdominal WallTurkey
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University College, LondonUniversity College London HospitalsUnknownVentral Hernia | Abdominal Wall DefectUnited Kingdom
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Bispebjerg HospitalCompleted
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University of Sao Paulo General HospitalCompletedAbdominal Wall Defect | Infection | Abdominal Wall Fistula | Abdominal Wall InfectionBrazil
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University of Sao Paulo General HospitalCompletedAbdominal Wall Defect | Infection | Abdominal Wall Hernia | Abdominal Wall Fistula | Abdominal Wall InfectionBrazil
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Centre Hospitalier Universitaire de BesanconRecruiting