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

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

Sponsors

Lead Sponsor: Geoffrey C. Gurtner

Source Stanford University
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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date July 2021
Primary Completion Date July 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of CSF leak 6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary Outcome
Measure Time Frame
Length of hospital stay 6 months active participation (date of surgery + 6 months follow up via chart review)
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)
Postoperative infection 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)
Enrollment 10
Condition
Intervention

Intervention Type: Device

Intervention Name: Duragen with Collagen Hydrodel and ASCs

Description: Duragen combined with collagen hydrogel and patient's stem cells

Arm Group Label: Hydrogel recipient

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Shannon Meyer

Phone: 650-736-5800

Email: [email protected]

Verification Date

July 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Geoffrey C. Gurtner

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Hydrogel recipient

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov