Omental Tissue Autograft for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is omental tissue autograft generally safe for use in humans?
How is the omental tissue autograft treatment for brain tumors different from other treatments?
The omental tissue autograft treatment is unique because it involves using a patient's own omental tissue (a layer of fat that covers abdominal organs) to potentially support brain tumor treatment, which is different from traditional methods like chemotherapy or radiation that target the tumor directly.678910
What data supports the effectiveness of the treatment Laparoscopically harvested omental tissue autograft for brain tumors?
Research shows that omental tissue, when transplanted to the brain, can help bypass the blood-brain barrier (a protective shield around the brain) and promote healing by providing blood supply and growth factors. This technique has been used successfully in other conditions like Alzheimer's disease and skull base reconstruction, suggesting it may help in brain tumor treatment by improving blood flow and supporting tissue repair.1231112
Who Is on the Research Team?
John Boockvar, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 with recurrent Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and can undergo MRI scans. They must have a life expectancy of at least 6 months, meet specific lab criteria, and not be pregnant or breastfeeding. Exclusions include active infections, other clinical trials participation, prior abdominal surgery, or severe renal issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Resection and Omental Autograft
Standard surgical resection for diagnosed recurrent GBM followed by lining the surgical cavity with a laparoscopically harvested piece of autologous omentum
Immediate Post-Surgical Follow-up
Participants are monitored for side effects such as seizures, stroke, and infection within 72 hours post-surgery
Extended Follow-up
Participants are monitored for safety and effectiveness, including tumor progression and survival, at 7 days, 30 days, 60 days, 120 days, and 180 days post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Laparoscopically harvested omental tissue autograft
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor