30
Participants
Start Date
January 25, 2024
Primary Completion Date
March 31, 2027
Study Completion Date
September 30, 2027
human Neural Stem Cells (hNSC)
The patient is placed on a regular operating room table with or without rigid head fixation. Procedure will be performed whether under general anesthesia or sedation and local anesthesia. Image guidance will be registered using the frameless stereotactic AxiEM system. Image guidance will be used to perform ventricular cannulation with the catheter passed over an electromagnetic-tipped stylet, which is recognized and tracked by the navigation system. The correct placement of the catheter is verified by the egress of CSF. Finally the electromagnetic stylet will be removed and a Rickam reservoir connect to ventricular catheter. Operative time will be about 30 minute. A post-operative CT scan will be obtained in all patients to confirm the catheter position.
Saline (Placebo)
The patient is placed on a regular operating room table with or without rigid head fixation. Procedure will be performed whether under general anesthesia or sedation and local anesthesia. Image guidance will be registered using the frameless stereotactic AxiEM system. Image guidance will be used to perform ventricular cannulation with the catheter passed over an electromagnetic-tipped stylet, which is recognized and tracked by the navigation system. The correct placement of the catheter is verified by the egress of CSF. Finally the electromagnetic stylet will be removed and a Rickam reservoir connect to ventricular catheter. Operative time will be about 30 minute. A post-operative CT scan will be obtained in all patients to confirm the catheter position.
RECRUITING
Centro SLA Azienda Ospedaliera Università Maggiore della Carità, Novara
NOT_YET_RECRUITING
Azienda Ospedaliera di Padova, Padua
NOT_YET_RECRUITING
Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo
NOT_YET_RECRUITING
"Azienza Ospedaliera Universitaria - Policlinico P. Giaccone Università degli Studi di Palermo", Palermo
Ministry of Health, Italy
OTHER_GOV
Casa Sollievo della Sofferenza IRCCS
OTHER