Using mesenchymal stromal cells to treat traumatic brain injury
MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury
PHASE2 · Fondazione IRCCS San Gerardo dei Tintori · NCT06163833
This study is testing if giving special cells through an IV can help people with severe traumatic brain injuries recover better within two weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori (other) |
| Locations | 3 sites (Monza, MB and 2 other locations) |
| Trial ID | NCT06163833 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cells (MSCs) administered intravenously to patients with severe traumatic brain injury (TBI) within 48 hours of injury. The study is a multicenter, double-blind, randomized, placebo-controlled phase II trial that will assess whether MSCs can reduce the levels of a biomarker associated with brain damage, neurofilament light (NFL), at 14 days post-treatment. Participants will be monitored for various clinical, neuroimaging, and biological parameters to understand the evolution of TBI and the potential benefits of MSC therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with severe TBI, as evidenced by CT scan abnormalities, and who can receive treatment within 48 hours of injury.
Not a fit: Patients with a high likelihood of death within the first 48 hours or those with significant pre-existing neurological impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from severe traumatic brain injury.
How similar studies have performed: While few clinical studies have assessed MSC therapy for TBI, preclinical data suggest promising outcomes, indicating that this approach is novel and has not been extensively tested in humans.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Monza, MB and 2 other locations
- 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)
Study contacts
- Principal investigator: Giuseppe Citerio, Professor — Fondazione IRCCS San Gerardo dei Tintori
- Study coordinator: Giuseppe Citerio, Professor
- Email: giuseppe.citerio@unimib.it
- Phone: +39 0392334316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury With Loss of Consciousness, mesenchimal stromal cells, neuroprotection, neurogenesis, cell therapy, synaptic plasticity, inflammation