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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04503161

Enrollment

Registered

2020-08-07

Start date

2021-09-30

Completion date

2022-09-30

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CSF Leak

Brief 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.

Interventions

DEVICEDuragen with Collagen Hydrodel and ASCs

Duragen combined with collagen hydrogel and patient's stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Rate of CSF leak	6 months active participation (date of surgery + 6 months follow up via chart review)

Secondary

Measure	Time frame
Need for reoperation	6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative hematoma	6 months active participation (date of surgery + 6 months follow up via chart review)
Length of hospital stay	6 months active participation (date of surgery + 6 months follow up via chart review)
Need for rehospitalization	6 months active participation (date of surgery + 6 months follow up via chart review)
Death	6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative infection	6 months active participation (date of surgery + 6 months follow up via chart review)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026