The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
  • Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)

Treatment groups

12 Participants
are divided into 2 treatment groups