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

CSF Leak Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leak

• NCT number: NCT04503161
• Study type: Interventional
• Source: Stanford University
• Status: Withdrawn
• Phase: N/A
• Start date: September 2021
• Completion date: September 2022