. 2023 Aug 25;11:56. doi: 10.1186/s40635-023-00535-1

Table 2.

Eligibility criteria

Inclusion criteria	Exclusion criteria
– Age: 18–70 years (inclusive) – Clinical frailty index < 5 [60] – Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall’s CT Classification > 1) – Study drug (MSCs/placebo) administration start within 48 h 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	– Motor GCS > 5 at recruitment – High likelihood (> 85%) of death in the first 48 h calculated by IMPACT calculator [61] 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) – Recent serious infectious process requiring ICU admission – Cancer (ongoing) – Immunosuppression – Human immunodeficiency virus – Positive urine pregnancy test or breastfeeding – 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

Inclusion criteria

Exclusion criteria

– Age: 18–70 years (inclusive)

– Clinical frailty index < 5 [60]

– Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall’s CT Classification > 1)

– Study drug (MSCs/placebo) administration start within 48 h 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

– Motor GCS > 5 at recruitment

– High likelihood (> 85%) of death in the first 48 h calculated by IMPACT calculator [61] 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)

– Recent serious infectious process requiring ICU admission

– Cancer (ongoing)

– Immunosuppression

– Human immunodeficiency virus

– Positive urine pregnancy test or breastfeeding

– 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

CT, computed tomography; GCS, Glasgow Coma Scale; ICP, intracranial pressure; ICU, intensive care unit; IMPACT, international mission for prognosis and clinical trial; MSCs, mesenchymal stromal cells; TBI, traumatic brain injury