[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602039":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":52,"collaborators":23,"id":54,"slug":23,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":23,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":23,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":23,"overallStatus":36,"whyStopped":23,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5.0×10^7 cells\u002Fperson\u002Fdose","EXPERIMENTAL","intrathecal injection",[13],"Drug: Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)",{"label":15,"type":10,"description":11,"interventionNames":16},"1.0×10^8 cells\u002Fperson\u002Fdose",[13],[18,24],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)","Injection, once, 6 months",[15,9],null,{"type":19,"name":20,"description":25,"armGroupLabels":26,"otherNames":23},"Injection, every two weeks for four doses, 6 months",[15,9],[28],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"Michael LEE","CONTACT","+86 21 64027719","CEO@xellsmart.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Peking University Third Hospital","RECRUITING","Beijing","Beijing Municipality","100191","China",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":23,"email":51},"Dongsheng Fan","+86 13701023871","dsfan@sina.com",{"type":53,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100602039",false,"NCT07118319","The Safety, Tolerability and Preliminary Efficacy of 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 Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. 18-75 years of age (inclusive of 18 and 75 years), regardless of gender;\n2. Diagnosed of definite or probable ALS according to the revised EI Escorial criteria;\n3. Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%);\n4. 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;\n5. Volunteer to participate in the clinical study, understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out;\n2. Baseline body mass index (BMI) \\\u003C 18.5 kg\u002Fm²;\n3. Primary lateral sclerosis presenting only with upper motor neuron symptoms;\n4. Significant psychiatric disorders that the investigator assesses may affect evaluation;\n5. Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis;\n6. Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation;\n7. Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled;\n8. Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis;\n9. Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation;\n10. Poorly controlled hypertension;\n11. Previous or detected cardiac abnormalities;\n12. A history of cirrhosis, chronic hepatitis, or liver function at screening;\n13. A history of chronic kidney disease;\n14. Previous history of bleeding, abnormal clotting, or being treated with anticoagulation;\n15. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening;\n16. History of severe trauma or surgery and may affect the assessment judged by investigator;\n17. Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure.\n18. Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy;\n19. Have participated in other clinical trials within 3 months prior to screening;\n20. Pregnant or breastfeeding women;\n21. Subject who is judged by the investigator to be unsuitable for the clinical trial.","ALL","18 Years","75 Years",{"count":64,"type":65},12,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","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",[71],"Amyotrophic Lateral Sclerosis (ALS)","2025-11-17",{"date":74,"type":75},"2025-11-21","ACTUAL",{"date":77,"type":75},"2025-09-15",{"date":79,"type":65},"2028-09-30",{"name":5,"class":6},1]