Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 25, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

September 30, 2027

Conditions
Amyotrophic Lateral Sclerosis
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (4)

28100

RECRUITING

Centro SLA Azienda Ospedaliera Università Maggiore della Carità, Novara

35128

NOT_YET_RECRUITING

Azienda Ospedaliera di Padova, Padua

71013

NOT_YET_RECRUITING

Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

90129

NOT_YET_RECRUITING

"Azienza Ospedaliera Universitaria - Policlinico P. Giaccone Università degli Studi di Palermo", Palermo

All Listed Sponsors
collaborator

Ministry of Health, Italy

OTHER_GOV

lead

Casa Sollievo della Sofferenza IRCCS

OTHER