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

NCT04503161 | Withdrawn DMC FDA Device

• 1 other identifier: IRB-52778
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Rate of CSF leak

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

Secondary Outcomes (6)

• 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)

Study Arms (1)

Hydrogel recipient

EXPERIMENTAL

Device: Duragen with Collagen Hydrodel and ASCs

Interventions

Duragen with Collagen Hydrodel and ASCs DEVICE

Duragen combined with collagen hydrogel and patient's stem cells

Hydrogel recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18
• Planned for skull base surgery
• Able to understand and willing to sign a written informed consent form

You may not qualify if:

• active skull base infection
• no plan for DuraGen repair by operating surgeon

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share