Status:
RECRUITING
Mesenchymal Stromal Cells for Traumatic Brain Injury
Lead Sponsor:
Fondazione IRCCS San Gerardo dei Tintori
Collaborating Sponsors:
Istituto Di Ricerche Farmacologiche Mario Negri
A.O. Ospedale Papa Giovanni XXIII
Conditions:
Traumatic Brain Injury With Loss of Consciousness
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 h...
Detailed Description
Study Description: Multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study meant to define if MSCs, administered at dosage of 80 or 160 x 10\^6 cells within 48h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06163833
Start Date
September 19 2023
End Date
December 1 2026
Last Update
December 11 2023
Active Locations (3)
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1
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy, 20900
2
ASST Ospedale Papa Giovanni XXIII Bergamo
Bergamo, Italy, 24127
3
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milano
Milan, Italy, 20122