A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis
18-75 years of age (inclusive of 18 and 75 years), regardless of gender;
Diagnosed of definite or probable ALS according to the revised EI Escorial criteria;
Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%);
Patients with birth-potential (both male and female) must agree to use effective non-drug contraceptive measures from the time of signing the informed consent until 6 months after the conclusion of the trial;
Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out;
Baseline body mass index (BMI) < 18.5 kg/m²;
Primary lateral sclerosis presenting only with upper motor neuron symptoms;
Significant psychiatric disorders that the investigator assesses may affect evaluation;
Sequential
Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
DrugInjection, once, 6 months
Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
DrugInjection, every two weeks for four doses, 6 months
The incidence of XS228CN-related adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last administration in ALS patients
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