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Use of stem cells for the treatment of traumatic brain injury. Multicenter, doubleblind, randomized with placebo phase II clinical trial.
EU CTIS ID: 2024-516510-38-00
What this study is testing
The study is meant: i) to define if MSCs, administered at dosage of 80 or 160 x 106 cells are safe in patients with severe TBI; ii) to define if MSCs, administered at the dosage found to be safe and more promising in terms of activity as revealed by the interim analysis, decrease the plasmatic NFfL biomarker of brain damage at 14 days post-TBI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: 18-70 years (inclusive)
- Clinical frailty index (CFI) < 5
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall’s CT Classification >1)
- Study drug (MSC/placebo) administration within 48 hours from TBI
- Glasgow Coma Scale (GCS) ≤ 8 at recruitment (last valid neurological assessment before randomization) and at least one pupil reactive to light
- ICP monitoring, already inserted or planned for clinical indications
You likely can't join if
- Motor GCS > 5 at recruitment (last valid neurological assessment before randomization)
- Recent serious infectious process requiring ICU admission
- Cancer (ongoing)
- Immunosuppression
- Previous known history of immunodeficiency syndromes, or current signs/symptoms suggesting immunodeficiency
- Positive urine pregnancy test
See the full eligibility criteria
- Age: 18-70 years (inclusive)
- Clinical frailty index (CFI) < 5
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall’s CT Classification >1)
- Study drug (MSC/placebo) administration within 48 hours from TBI
- Glasgow Coma Scale (GCS) ≤ 8 at recruitment (last valid neurological assessment before randomization) and at least one pupil reactive to light
- ICP monitoring, already inserted or planned for clinical indications
- Weight < 100 Kg and > 40 kg
- Motor GCS > 5 at recruitment (last valid neurological assessment before randomization)
- Recent serious infectious process requiring ICU admission
- Cancer (ongoing)
- Immunosuppression
- Previous known history of immunodeficiency syndromes, or current signs/symptoms suggesting immunodeficiency
- Positive urine pregnancy test
- Known risk/history of coagulopathy and thromboembolism
- Pre-existing and severe ongoing: • 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; Citratedextrose solution, ACD)
- Participation in a concurrent interventional study
- High likelihood (>85%) of death in the first 48 h calculated by IMPACT (International Mission for Prognosis and Analysis of Clinical Trials in TBI) calculator128 on early admission data
- Bilateral unreactive mydriasis
- Opening ICP > 40 mmHg
- Known history of prior brain injury, psychiatric disorder, neurological impairment and/or deficit
- Brain penetrating injury
- Spinal cord injury
- Epilepsy requiring ongoing anti-convulsant therapy
- Severe organ failure (including PaO2/FiO2<200 and shock)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.