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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04503161
• Other study ID #: IRB-52778
• Status: Withdrawn
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leak

Intervention

Device:
• Duragen with Collagen Hydrodel and ASCs
Duragen combined with collagen hydrogel and patient's stem cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CSF leak		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Length of hospital stay		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Need for reoperation		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Postoperative hematoma		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Postoperative infection		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Need for rehospitalization		6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary	Death		6 months active participation (date of surgery + 6 months follow up via chart review)