Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS) - Trial NCT06344260
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.
Study Focus
Sponsor & Location
Casa Sollievo della Sofferenza IRCCS
Timeline & Enrollment
Phase 2
Jan 25, 2024
Sep 01, 2027
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
Data Source
ClinicalTrials.gov
NCT06344260
Non-Device Trial