MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury
Methods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study. Duration of the study: 36 months (24 of enrolment and 12 of follow up). Funding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call Unmet medical needs, proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).
• Age: 18-70 years
• Clinical frailty index (CFI) \< 5
• Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall's CT Classification \>1)
• Feasibility of study drug (MSC/placebo) administration within 48 hours from TBI
• GCS ≤ 8 at recruitment and at least one pupil reactive to light
• ICP monitoring already inserted or planned for clinical indications
• Weight \< 100 Kg and \> 40 kg