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MATRIx: MSCs for Traumatic Brain Injury
NCT06163833Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2023
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Modality
- Mesenchymal Stem Cells
- Drugs
- Provacel
- Conditions
- traumatic brain injury (TBI)
01
Overview
Phase 2, randomised, double-blind trial of Provacel in traumatic brain injury (TBI) (3 arms), sponsored by Fondazione IRCCS San Gerardo dei Tintori. Primary endpoints: Serious Adverse Drug Reaction at 14 days and Neurofilament Light at 14 days. Started Sep 2023; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo storage solution
MSCs 80M
80 x 10^6 MSCs
MSCs 160M
160 x 10^6 MSCs
03
Endpoints
Primary
Serious Adverse Drug Reaction
Neurofilament Light
Secondary
Brain Injury Evolution and White Matter Damage
Circulating Biomarkers of Brain Damage and Neuroinflammation
Clinical and Neuropsychological Outcome
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