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NCT06344260Recruiting

Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS)

Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis: A Multicenter, Randomized Placebo Controlled and Biological Endpoints Clinical Trial
Casa Sollievo della Sofferenza IRCCSPhase 2ClinicalTrials.govprocedure
Verified
Study focus
Disease/Condition
Amyotrophic Lateral Sclerosis
Drug/Device/Intervention
human Neural Stem Cells (hNSC)
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Casa Sollievo della Sofferenza IRCCS
Location
San Giovanni Rotondo,Novara,Padua,Palermo, Italy
Timeline & enrollment
Phase
Phase 2
Start date
Jan 25, 2024
End date
Sep 01, 2027
Enrollment
30 participants
Primary outcome

Safety of treatment

Summary

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.

ICD-10 classifications
Neuralgic amyotrophyMotor neuron diseaseOther degenerative diseases of the nervous systemOther degenerative disorders of nervous system in diseases classified elsewhereMultiple sclerosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06344260
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06344260 through Pure Global AI's free database. This Phase 2 trial is sponsored by Casa Sollievo della Sofferenza IRCCS and is currently Recruiting. The study focuses on Amyotrophic Lateral Sclerosis. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.