Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT06163833
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06163833
Study Brief:
Protocol Section:
NCT06163833