Tests stem-cell-derived motor neuron cells in amyotrophic lateral sclerosis
Tests XS228CN, cells made from stem cells, in adults with ALS.
Plain-language title generated from the registry record
Registry title: The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07118319, who can take part
Where in China
- Peking University Third HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
- Trial code
- NCT07118319
- Record updated
- 21 November 2025
- Original description
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral SclerosisRead full original descriptionShow less
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
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
Inclusion: 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: Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled; Previous or detected cardiac abnormalities; Previous history of bleeding, abnormal clotting, or being treated with anticoagulation; 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; 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; 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; A history of cirrhosis, chronic hepatitis, or liver function at screening; A history of chronic kidney disease; 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; 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; Pregnant or breastfeeding women; Subject who is judged by the investigator to be unsuitable for the clinical trial.