Recruiting

Omental Tissue Autograft

Sponsor:

Northwell Health

Code:

NCT05979064

Conditions

Glioma

Glioma, Malignant

Glioblastoma

Glioblastoma Multiforme

Glioblastoma Multiforme of Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laparoscopically harvested omental tissue autograft

Study Details

Brief summary:

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.

Conditions

Glioma

Glioma, Malignant

Glioblastoma

Glioblastoma Multiforme

Glioblastoma Multiforme of Brain

Study ID

NCT05979064

Start date

Apr 4, 2023

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject is a male or female 18 years of age or older.
2. Subject is undergoing planned resection of known or suspected GBM.
3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
6. Subject must be able to undergo MRI evaluation.
7. Subject meets the following laboratory criteria:

1. White blood count ≥ 3,000/μL
2. Absolute neutrophil count ≥ 1,500/μL
3. Platelets ≥ 100,000/μL
4. Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)
5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
7. Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN
8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document

Inclusion criteria considered during surgery:

1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
2. Omental graft is technically feasible.

Exclusion Criteria:

1. Subject, if female, is pregnant or is breast feeding.
2. Subject intends to participate in another clinical trial.
3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
4. Subject has an active infection requiring treatment.
5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.
10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
11. Subject who are unable to have an MRI scan for any reason.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Laparoscopically harvested omental tissue autograft

Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.

Interventions

Laparoscopically harvested omental tissue autograft

1. Standard neurosurgical removal of recurrent GBM,
2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically),
3. the omental fat will be transferred and implanted into brain tumor cavity,
4. standard closure of surgical resection cavity.

Primary outcome measure

  • Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM). [ Time Frame: Study Day 1 - Day 180 ]
  • Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection. [ Time Frame: Study Day 1 - Day 180 ]

Central Contacts and Locations

Central contacts

Locations

Lenox Hill Brain Tumor Center

Recruiting

New York, New York, United States, 10075

Contacts

Principal Investigator:

John Boockvar, MD

More Information

Sponsor

Northwell Health

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • blood brain barrier
  • omentum autograft
  • omental autograft
  • omentum
  • omental

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-01.