Mesenchymal Stromal Cells for Traumatic Brain Injury

Launched by FONDAZIONE IRCCS SAN GERARDO DEI TINTORI · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a type of cell therapy using mesenchymal stromal cells (MSCs) can help improve outcomes for patients with severe traumatic brain injury (TBI) who have lost consciousness. TBI can cause serious, long-lasting effects, and currently, there aren’t any treatments that specifically protect the brain from further damage. In this study, researchers will administer MSCs or a placebo (an inactive substance) to participants within 48 hours of their injury. The trial aims to find out how safe the treatment is and whether it can reduce signs of brain damage, using blood tests and brain scans to measure progress over time.

To be eligible for this study, participants must be between 18 and 70 years old, have a confirmed diagnosis of TBI based on a CT scan, and have a certain level of consciousness. They should also meet specific health criteria, such as not having severe organ failure or other significant medical conditions. The trial will take about three years, with the first two years focused on enrolling participants and the last year following up on their progress. Those who join the study can expect regular health assessments and imaging tests to monitor their recovery. This research is important as it could lead to new treatments that help improve the lives of TBI survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Motor GCS \> 5 at recruitment
• • High likelihood (\> 85%) of death in the first 48 h calculated by IMPACT calculator on early admission data
• • Bilateral mydriasis
• • Opening ICP \> 40 mmHg
• • Known history of prior brain injury, psychiatric disorder, neurological impairment and/or deficit
• • Brain penetrating injury
• • Spinal cord injury
• • Previous epilepsy requiring anti-convulsant therapy
• • Severe organ failure (including PaO2/FiO2\<200 and shock)
• • Recent serious infectious process
• • Cancer
• • Immunosuppression
• • Human immunodeficiency virus
• • Positive urine pregnancy test or nursing
• • Known risk/history of coagulopathy and thromboembolism
• * Pre-existing and severe:
• • lung disease (such as asthma, chronic obstructive pulmonary disease),
• • heart dysfunction (as heart failure and reduced cardiac output),
• • liver insufficiency (as cirrhosis)
• • kidney insufficiency
• • and other organ severe abnormalities
• • Known hypersensitivity to excipients used in the formulation (Dimethyl sulfoxide (DMSO), Citrate-dextrose solution (ACD))
• • Participation in a concurrent interventional study