[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai IxCell Biotechnology Co., LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100608134","phase-2-clinical-trial-of-umbilical-cord-mesenchymal-stem-cells-in-subacute-ischemic-stroke-100608134",false,"NCT07197606","Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke","A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase","Inclusion Criteria:\n\n* Age ≥18 years and ≤70 years, regardless of gender.\n* 14 to 90 days after ischemic stroke.\n* Clinical diagnosis of anterior circulation ischemic stroke.\n* National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score \\\u003C2 points.\n* It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.\n\nExclusion Criteria:\n\n* People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.\n* Intracranial hemorrhagic conditions.\n* Pre-stroke mRS score \\>1.\n* Severe cardiovascular disease.\n* Severe pulmonary diseases.","ALL","18 Years","70 Years",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.",[27],"Ischemic Stroke","NOT_YET_RECRUITING","2025-09-22",{"date":31,"type":32},"2025-09-29","ACTUAL",{"date":34,"type":21},"2025-10-01",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Shanghai IxCell Biotechnology Co., LTD","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100579343","phase-1-clinical-trial-of-human-umbilical-cord-mesenchymal-stem-cells-ixcell-huc-msc-p-in-the-treatment-of-ctd-ild-100579343","NCT06823063","Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD","A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease","Inclusion Criteria:\n\n1. Both sexes, aged 18-80 years;\n2. SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR\u002FEULA) criteria:\n3. Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);\n4. The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:\n\n   1. A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;\n   2. A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;\n   3. Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.\n   4. Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);\n   5. Worsening of pulmonary fibrosis on HRCT + worsening of clinical symptoms (worsening of lung imaging + worsening of symptoms) within 24 months despite treatment;\n5. Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;\n6. The patient was able to complete the 6-Minute Walk Test (6MWT);\n7. Be able to understand and complete pulmonary function test procedures.\n8. Fully informed experiment purposes, methods, and possible uncomfortable, willing to medicine and follow-up inspection on time, according to the requirements of plan agreed to participate in trials, and sign the informed consent.\n\nExclusion Criteria:\n\n1. The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.\n2. Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);\n3. History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;\n4. History of myocardial infarction or angina pectoris within 6 months before enrollment;\n5. Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;\n6. Allergic to any component of the medication;\n7. Life expectancy of less than 1 year due to diseases other than SSc;\n8. Planned surgical procedures during the trial;\n9. Has a history of scleroderma kidney crisis;\n10. Patients who had used glucocorticoids within 2 weeks before enrollment but could not maintain the dosage ≤10mg\u002F d equivalent prednisone;\n11. Patients who had used methotrexate within 2 months before enrollment, or failed to maintain a stable dosage while using other immunosuppressants;\n12. Into groups of 2 months before used anti fibrosis drug (such as pyrazole ketone, dani, cloth, etc.);\n13. Patients treated with rituximab, tocilizumab and mesenchymal stem cells within 2 months before enrollment;\n14. Patients with other systemic diseases and organ dysfunction (ALT\\>1.5 times upper limit of normal; Cr\\>1.5 times upper limit of normal; LVEF≤40%; Other progressive or uncontrolled diseases);\n15. Active hepatitis, tuberculosis, HIV infection;\n16. Patients with malignant tumors or a history of cancer;\n17. Pregnant or lactating women or those who have recently planned to have children and cannot take effective contraceptive measures;\n18. People with a history of alcohol or drug abuse;\n19. Enrolled in another drug trial within 3 months before enrollment;\n20. Unable to complete all assessors;\n21. And anyone who was deemed by the investigator to be ineligible for inclusion.","80 Years",{"count":50,"type":21},18,[52],"PHASE1","To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.\n\nTo evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).",[55],"CTD-ILD","2025-02-12",{"date":58,"type":32},"2025-02-14",{"date":60,"type":21},"2025-04-01",{"date":62,"type":21},"2026-12-31",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":48,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100571133","phase-3-efficacy-and-safety-of-ixcell-huc-msc-o-in-patients-with-knee-osteoarthritis-100571133","NCT06716281","Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n1. Patients diagnosed with knee osteoarthritis according to the \"Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)\" by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association;\n2. Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal anti-inflammatory drugs, viscosupplementary therapy, etc.;\n3. The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;\n4. Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;\n5. Patients with a VAS pain score of ≥50mm (total score of 100mm) in the study side knee joint at the time of screening;\n6. Ages between 40 and 80, with no gender restrictions. BMI (Body Mass Index, weight \\[kg\\]\u002Fheight\\^2 \\[m\\^2\\]) ≤30;\n7. Able to understand and voluntarily sign the informed consent form, and willing to complete the trial procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Patients diagnosed with secondary knee osteoarthritis;\n2. Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis, symptomatic chondrocalcinosis, osteonecrosis, or active infections, lower limb arteriosclerosis obliterans, etc.);\n3. Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;\n4. Patients who have previously used stem cell therapy;\n5. Patients who have received opioid, non-steroidal anti-inflammatory analgesics, or any other pain-relieving medication for knee osteoarthritis within 2 weeks or 7 half-lives (whichever is longer) before treatment;\n6. Patients who have received physiotherapy or traditional Chinese medicine treatment for knee arthritis (either side) within 6 weeks before treatment;\n7. Patients who have received local injection of glucocorticoids, anesthetics, or local application of glucocorticoids for the knee joint (either side) within 12 weeks before treatment, or who have received systemic glucocorticoid treatment within 12 weeks, or who require systemic glucocorticoid treatment during the study;\n8. Patients who started taking glucosamine, chondroitin sulfate, or diacerein within 4 weeks before treatment (except those who have been taking glucosamine or chondroitin sulfate for a long time and have continued to take them for 4 weeks before treatment and are willing to maintain the dosage and frequency during the study);\n9. Patients who have received any drug injection treatment in the knee joint cavity (either side) within 6 months before treatment;\n10. Patients who have undergone major surgery, arthroplasty, or arthroscopy on the study side knee joint within 24 weeks before signing the informed consent form, or those who plan to undergo surgical treatment on the study side knee joint during the study;\n11. Patients who have undergone surgical treatment on the lower limbs (hip or knee) within 12 weeks before signing the informed consent form;\n12. Patients whose study side knee joint is not suitable for MRI examination, such as those with metal implants affected by magnetic fields;\n13. Patients who plan to undergo any type of lower limb surgery within 48 weeks after signing the informed consent form;\n14. Patients with skin diseases or skin infections around the intended injection site;\n15. Patients with osteoarthritis on the opposite side of the study knee joint and who plan to undergo intra-articular drug therapy during the study;\n16. Patients with hip joint disease on the same side as the study knee joint and who require medical intervention (such as severe hip osteoarthritis);\n17. Patients with a history of allergic reactions to any components of the trial medication;\n18. Patients with current malignant tumors or a history of malignant tumors within 5 years before signing the informed consent form;\n19. Patients with a clear history of mental disorders, or a history of abuse of psychotropic drugs or drug use;\n20. Patients with severe heart disease (NYHA Class III or above), or liver function abnormalities (serum ALT \\> 3×ULN or AST \\> 3×ULN), or kidney function abnormalities (serum Cr \\> 2×ULN or BUN \\> 2×ULN), or coagulation disorders (INR \\> 1.5), or severe hematological diseases (such as anemia of grade 3 or above, Hb \\\u003C 8g\u002FdL, or thrombocytopenia of grade 2 or above, Plt \\\u003C 75×10\\^9\u002FL);\n21. Patients with HBeAg-positive chronic hepatitis B (defined by the 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B), or hepatitis C virus infection, or positive for human immunodeficiency virus antibodies, or positive for Treponema pallidum antibodies;\n22. Female patients who are pregnant or breastfeeding, or male and female patients who refuse to use contraceptive measures (abstinence, physical contraception, or hormonal contraceptives starting 3 months before enrollment) from the study period to 6 months after the last visit;\n23. Patients who have participated in any other clinical trials within 3 months before signing the informed consent form;\n24. Patients deemed unsuitable for participation in this trial by the investigator for other reasons.","40 Years",{"count":73,"type":21},398,[75],"PHASE3","To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.\n\nTo evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.",[78],"Knee Osteoarthritis","RECRUITING","2024-12-03",{"date":82,"type":32},"2024-12-06",{"date":84,"type":32},"2024-01-05",{"date":86,"type":21},"2025-12-31",{"name":38,"class":39},""]