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New treatment option for Traumatic Brain Injury With Loss of Consciousness
Official title Mesenchymal Stromal Cells for Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06163833
What this study is testing
What is Mesenchymal stromal cell low dosage-80*10^6 cells?
Mesenchymal stromal cell low dosage-80*10^6 cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for traumatic brain injury with loss of consciousness.
Also referred to as MATRIx MSC low dose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 \ 40 kg
- 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 treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Monza, MB, Italy
- Bergamo, Italy
- Milan, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monza, MB, Italy; Bergamo, Italy; Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.