The Effect of an ASC-seeded Collagen Hydrogel on Cerebros... | NCT04503161

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

NCT04503161

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Aug 29, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

CSF Leak

Interventions

Duragen with Collagen Hydrodel and ASCs

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator left institution

Expanded Access Info

Start Date

Sep 2021Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Aug 3, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrogel recipient	Experimental		Device: Duragen with Collagen Hydrodel and ASCs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duragen with Collagen Hydrodel and ASCs	Device	Duragen combined with collagen hydrogel and patient's stem cells	Hydrogel recipient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002558	Cerebrospinal Fluid Otorrhea

Ancestor Terms

ID	Term
D065634	Cerebrospinal Fluid Leak
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided