Condition: Traumatic Brain Injury With Loss of Consciousness · Sponsor: Fondazione IRCCS San Gerardo dei Tintori
Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI. Aim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10\^6 MSCs vs 160 x 10\^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal dama…
This description comes directly from the study's public registry record.
Giuseppe Citerio, Professor · +39 0392334316 · giuseppe.citerio@unimib.it
Alessia Vargiolu, PhD · +39 0392334335 · alessia.vargiolu@unimib.it
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| Fondazione IRCCS San Gerardo dei Tintori | Monza, MB, Italy | Recruiting |
| ASST Ospedale Papa Giovanni XXIII Bergamo | Bergamo, Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milano | Milan, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06163833