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

Primary Purpose

CSF Leak

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Duragen with Collagen Hydrodel and ASCs

About this trial

This is an interventional prevention trial for CSF Leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrogel recipient

Arm Description

Outcomes

Primary Outcome Measures

Rate of CSF leak

Secondary Outcome Measures

Length of hospital stay

Need for reoperation

Postoperative hematoma

Postoperative infection

Need for rehospitalization

Death

Full Information

NCT ID

NCT04503161

First Posted

August 3, 2020

Last Updated

August 23, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04503161

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator left institution

Study Start Date

September 2021 (Anticipated)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CSF Leak

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrogel recipient

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Duragen with Collagen Hydrodel and ASCs

Intervention Description

Duragen combined with collagen hydrogel and patient's stem cells

Primary Outcome Measure Information:

Title

Rate of CSF leak

Time Frame