Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

NCT02416674 | Unknown Early Phase 1

• 1 other identifier: 2013P002556
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Abdominal Wall Defect

Keywords

abdominal wall; vascularized composite allotransplantation

Outcome Measures

Primary Outcomes (1)

• allograft survival

  5 years

Secondary Outcomes (3)

• immune rejection episodes

  5 years

• infections

  5 years

• donation of abdominal wall

  5 years

Study Arms (1)

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.

Procedure: abdominal wall transplantation; Drug: Immunosuppressive Agents

Interventions

abdominal wall transplantation PROCEDURE

transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.

Also known as: vascularized composite allotransplantation

Transplant recipients

Immunosuppressive Agents DRUG

Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.

Transplant recipients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Vascularized Composite Allotransplantation; Immunosuppressive Agents

Intervention Hierarchy (Ancestors)

Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bohdan Pomahac, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Detmer-Lillard

CONTACT

6177327874

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Plastic Surgery Transplantation

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)