FRRB Project 3440227 - Mesenchymal stromal cells for curing traumatic brain injury
The Coordinator of the project is Fondazione I.R.C.C.S. San Gerardo dei Tintori. The Lead Principal Investigator of the project is Prof. Giuseppe Citerio.
| Pathology: | Traumatic Brain Injury |
| Tematic Area: | Neurology - Rare Diseases |
| Project Start Date: | May 15, 2023 |
| Project End Date: | May 14, 2026 |
| Funding: | € 1.142.193,96 |
| Project Partners: | - Fondazione I.R.C.C.S. San Gerardo dei Tintori - Istituto di Ricerche Farmacologiche Mario Negri - Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico - ASST Ospedale Papa Giovanni XXIII |
PROGETTO SUMMARY
Traumatic brain injury (TBI, Orpha code 90056) is an important cause of death and disability, imposing a huge burden on patients, their families, and society. At 6 months, the functional outcome is still poor for severe TBI, with 20% mortality and severe disability in 40%. All the trials using neuroprotective drugs/strategies in the last decades failed, leaving the disease without a potential cure. Finding a therapy for TBI is, therefore, a priority. In this context, mesenchymal stromal cell (MSC)-based therapy represents an ideal approach as documented by our research consortium in the lab in the last decade: intravenous infusion of MSCs in the acute phase after experimental TBI improves functional and anatomical damage, stimulate neurogenesis, synaptic plasticity, axonal sprouting, vascular rescue, and induce immunomodulatory changes on recruited monocytes and resident microglia. Experimental and clinical data support the use of allogeneic MSCs in the clinical setting. To this end, we propose a double-blind, randomized, placebo-controlled, adaptive phase II dose-finding study designed to assess the safety and efficacy of allogeneic bone marrow-derived MSCs intravenously administered in TBI patients.