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Recruiting NCT07118319

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

Phase I Interventional Amyotrophic Lateral Sclerosis (ALS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis

Overview

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

Interventions

  • Drug Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
    Injection, once, 6 months
  • Drug Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
    Injection, every two weeks for four doses, 6 months

Primary outcome measures

  • The incidence of XS228CN-related adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last administration in ALS patients [Time frame: within 28 days after the last administration]

Eligibility criteria

Inclusion criteria

  • 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;
  • Volunteer to participate in the clinical study, understand and sign the informed consent form.

Exclusion criteria

  • 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;
  • Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis;
  • Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation;
  • Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled;
  • Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis;
  • Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation;
  • Poorly controlled hypertension;
  • Previous or detected cardiac abnormalities;
  • A history of cirrhosis, chronic hepatitis, or liver function at screening;
  • A history of chronic kidney disease;
  • Previous history of bleeding, abnormal clotting, or being treated with anticoagulation;
  • Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening;
  • History of severe trauma or surgery and may affect the assessment judged by investigator;
  • Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure.
  • Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy;
  • Have participated in other clinical trials within 3 months prior to screening;
  • Pregnant or breastfeeding women;
  • Subject who is judged by the investigator to be unsuitable for the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07118319 · XS228-Allo-ALS-CN1/2-P01 · 2025LP01221

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗