78
Participants
Start Date
September 19, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2026
Mesenchymal stromal cell low dosage-80*10^6 cells
"MSCs have to be administered at the dosage of 80\*10\^6. MSCs have to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI.~They have to be diluted 1:2 in a saline solution for a total of 36mL."
Mesenchymal stromal cell low dosage-160*10^6 cells
"MSCs have to be administered at the dosage of 160\*10\^6. MSCs have to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI.~They have to be diluted 1:2 in a saline solution for a total of 36mL."
Placebo-storage solution
Placebo has to be administered by intravenous infusion via an in situ venous catheter within 15 minutes from the preparation and within 48 hours from TBI. It has to be diluted 1:2 in a saline solution for a total of 36mL.
NOT_YET_RECRUITING
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milano, Milan
RECRUITING
Fondazione IRCCS San Gerardo dei Tintori, Monza
RECRUITING
ASST Ospedale Papa Giovanni XXIII Bergamo, Bergamo
Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
A.O. Ospedale Papa Giovanni XXIII
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Fondazione IRCCS San Gerardo dei Tintori
OTHER