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

August 23, 2022 updated by: Stanford University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrogel recipient
Device: Duragen with Collagen Hydrodel and ASCs
Duragen combined with collagen hydrogel and patient's stem cells

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-52778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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