An interventional study of Duragen with Collagen Hydrodel and ASCs in CSF Leak, sponsored by Stanford University. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
45 studies on the registry are indexed under Cerebrospinal Fluid Leak; 10 are open to participants now.
Browse Cerebrospinal Fluid Leak studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
Device: Duragen with Collagen Hydrodel and ASCs
Duragen combined with collagen hydrogel and patient's stem cells
Rate of CSF leak
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Stanford University