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allogeneic bone marrow-derived mesenchymal stromal cells (Fondazione IRCCS San Gerardo dei Tintori)
- Development stage
- Unknown
- Lead developer
- Fondazione IRCCS San Gerardo dei Tintori
- Modality
- Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous
01
Overview
This investigational cell-based therapy consists of allogeneic bone marrow-derived mesenchymal stromal cells (MSCs) developed by Fondazione IRCCS San Gerardo dei Tintori for the treatment of severe traumatic brain injury (TBI). Manufactured under Good Manufacturing Practices (GMP) at the Laboratorio Stefano Verri cell factory, the therapy is administered intravenously within 48 hours of injury. Unlike traditional cell replacement therapies, these MSCs function through pleiotropic mechanisms, including immunomodulation, neuroprotection, and the promotion of endogenous brain repair by releasing a variety of soluble factors and trophic molecules. The therapy is currently being evaluated in the Phase II MATRIx trial, which assesses safety, optimal dosing, and efficacy using neurofilament light (NfL) levels as a primary biomarker of neuronal damage.
- Other names
- mesenchymal stromal cellsMSCsMATRIx MSCs
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