protocolSection identificationModule nctId: NCT06344260, orgStudyIdInfo id: hNSCALSII, briefTitle: Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS), acronym: STEMALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Casa Sollievo della Sofferenza IRCCS, class: OTHER, collaborators name: Ministry of Health, Italy, descriptionModule briefSummary: A Not for Profit Phase II Study to Evaluate Safety, Efficacy and Biomarkers secondary endpoints of Human Neural Stem cell intracerebroventricular transplantation in amyotrophic lateral sclerosis patients: a randomized, placebo controlled, triple blind study.This is an approximate 24-months study (PHASE B) consisting, per patient, of a 30-day screening period, 12-month enrollment and follow up period. A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses. The study will be stopped when all the subjects included in the treatment period complete the study visits. The study uses an ATMP, for that reason all the patients follow up will be prosecuted long life., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an approximate 24-months triple-blinded, randomized, controlled vs placebo, in three arms study (PHASE B). A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses.In the phase B three arms will be: 1) hNSCs 20 milion cells 2) hNSCs 40 milion cells 3) Saline (comparator), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In order to blind also the statistician that will analyse the results the protocol has been designed as a triple-blinded protocol. This means that both the researchers, which include neurologist, neurosurgeon and biologist, as well as the patients and the statisticians are unaware of whether the participant received the treatment or the placebo (only IMP Manufacturer QP is unblinded since release the cell drug to the use in the surgery room), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: human Neural Stem Cells (hNSC), interventions name: Saline (Placebo), outcomesModule primaryOutcomes measure: Safety of treatment, secondaryOutcomes measure: Biological Endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa Sollievo Della Sofferenza IRCCS, status: NOT_YET_RECRUITING, city: San Giovanni Rotondo, state: Foggia, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Centro SLA Azienda Ospedaliera Università Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Letizia Mazzini, MD, role: CONTACT, phone: +39 0321 3733962, email: ambulatorio.sla@maggioreosp.novara.it, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Azienda Ospedaliera di Padova, status: NOT_YET_RECRUITING, city: Padua, zip: 35128, country: Italy, contacts name: Gianni Sorarù, MD, role: CONTACT, phone: +39049-8213645/646, email: cl.neurologica@aopd.veneto.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienza Ospedaliera Universitaria - Policlinico "P. Giaccone" Università degli Studi di Palermo, status: NOT_YET_RECRUITING, city: Palermo, zip: 90129, country: Italy, contacts name: Vincenzo La Bella, MD, role: CONTACT, phone: +39 091 6555158, email: info@centroslapalermo.it, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False