WithdrawnNot Applicable

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

Stopped: Investigator left institution

0Started 2021-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of CSF leak

Timeframe: 6 months active participation (date of surgery + 6 months follow up via chart review)

Trial details

NCT IDNCT04503161

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09

View on ClinicalTrials.gov More CSF Leak trials