CSF LeakNCT04503161
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
A study testing Duragen with Collagen Hydrodel and ASCs in people with CSF Leak, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CSF Leak
- What is being tested?
- Duragen with Collagen Hydrodel and ASCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >/= 18
- Planned for skull base surgery
- Able to understand and willing to sign a written informed consent form
Who cannot join
- active skull base infection
- no plan for DuraGen repair by operating surgeon
About this study
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
- Being tested
- Duragen with Collagen Hydrodel and ASCs
- Medical subject headings
- Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duragen with Collagen Hydrodel and ASCsDevice
Duragen combined with collagen hydrogel and patient's stem cells
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel recipient | Experimental | Not described Receives: Device: Duragen with Collagen Hydrodel and ASCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CSF leak
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Secondary outcomes (6)
Length of hospital stay
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Need for reoperation
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative hematoma
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative infection
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Need for rehospitalization
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Death
Measured: 6 months active participation (date of surgery + 6 months follow up via chart review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503161
- Sponsor's protocol ID
- IRB-52778
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
- ClinicalTrials.gov ID
- NCT04503161
- Acronym / sponsor ID
- IRB-52778
- Conditions
- CSF Leak
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrogel recipient | Experimental | Device: Duragen with Collagen Hydrodel and ASCs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18
- Planned for skull base surgery
- Able to understand and willing to sign a written informed consent form
Key exclusion criteria (2 listed)
- active skull base infection
- no plan for DuraGen repair by operating surgeon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duragen with Collagen Hydrodel and ASCsDuragen combined with collagen hydrogel and patient's stem cells | Device | Hydrogel recipient |
Primary outcome
Rate of CSF leak
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
6 secondary outcomes
Length of hospital stay
Time frame: 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)
Postoperative hematoma
Time frame: 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)
Need for rehospitalization
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
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CSF Leak
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Duragen with Collagen Hydrodel and ASCs in people with CSF Leak, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CSF leak (time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.