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

NCT ID: NCT04503161

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-09-30

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.

Conditions

CSF Leak

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hydrogel recipient

Group Type: EXPERIMENTAL

Duragen with Collagen Hydrodel and ASCs

Intervention Type: DEVICE

Duragen combined with collagen hydrogel and patient's stem cells

Interventions

Duragen with Collagen Hydrodel and ASCs

Duragen combined with collagen hydrogel and patient's stem cells

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB-52778

Identifier Type: -

Identifier Source: org_study_id