The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery

Stanford University

Status: Withdrawn

Conditions: CSF Leak

Treatments: Device: Duragen with Collagen Hydrodel and ASCs

Study type: Interventional

Funder types: Other

Identifiers

NCT04503161

IRB-52778

Details and patient eligibility

About

This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >/= 18
• Planned for skull base surgery
• Able to understand and willing to sign a written informed consent form

Exclusion criteria

• active skull base infection
• no plan for DuraGen repair by operating surgeon

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Hydrogel recipient

Experimental group

Treatment:

Device: Duragen with Collagen Hydrodel and ASCs