Abdominal Wall DefectEarly Phase 1NCT02416674
Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
A Early Phase 1 study testing abdominal wall transplantation and Immunosuppressive Agents in people with Abdominal Wall Defect, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Wall Defect
- What is being tested?
- abdominal wall transplantation and Immunosuppressive Agents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to Feb 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jessica Detmer-Lillard contact
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ashley Tremblay, 617-732-7796, atremblay1@bwh.harvard.edu
Elaine Devine, LSW, 617-732-6967, edevine2@bwh.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Abdominal Wall Defect
- Being tested
- abdominal wall transplantation, Immunosuppressive Agents
- Keywords
- abdominal wall, vascularized composite allotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal wall transplantationProcedure or surgery
Also called vascularized composite allotransplantation
transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.
Immunosuppressive AgentsDrug
Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.
| Study group | Role | What they receive |
|---|---|---|
| Transplant recipients | Experimental | The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect. Receives: Procedure: abdominal wall transplantation; Drug: Immunosuppressive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
allograft survival
Measured: 5 years
Secondary outcomes (3)
immune rejection episodes
Measured: 5 years
infections
Measured: 5 years
donation of abdominal wall
We will investigate how families of deceased organ donors respond to the request for donation of the abdominal wall tissues
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start1 Mar 2015
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall DefectStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bohdan Pomahac, Brigham and Women's Hospital
- Investigators
- Bohdan Pomahac, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416674
- Sponsor's protocol ID
- 2013P002556
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2015
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
- ClinicalTrials.gov ID
- NCT02416674
- Acronym / sponsor ID
- 2013P002556
- Conditions
- Abdominal Wall Defect
- Keywords
- abdominal wall, vascularized composite allotransplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant recipients | Experimental | Procedure: abdominal wall transplantation, Drug: Immunosuppressive AgentsThe intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal wall transplantationAlso: vascularized composite allotransplantationtransfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect. | Procedure or surgery | Transplant recipients |
| Immunosuppressive AgentsRecipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone. | Drug | Transplant recipients |
Primary outcome
allograft survival
Time frame: 5 years
3 secondary outcomes
immune rejection episodes
Time frame: 5 years
infections
Time frame: 5 years
donation of abdominal wall
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Detmer-Lillard contact
Bohdan Pomahac, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing abdominal wall transplantation and Immunosuppressive Agents in people with Abdominal Wall Defect, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Detmer-Lillard (6177327874), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
allograft survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.