[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Asia Cell Therapeutics (Shanghai) 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,[8,43,65],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100513230","phase-1-safety-and-tolerance-of-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-patients-with-ankylosing-spondylitis-100513230",false,"NCT05962762","Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Ankylosing Spondylitis","A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of aCell Injection of Allogeneic UC-MSCs in Patients With Ankylosing Spondylitis","Inclusion Criteria:\n\n* A definitive diagnosis of ankylosing spondylitis (AS) (according to the 1984 New York Revised Criteria, Annex 1) with active AS. Active AS is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4. Active AS is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4;\n* Received at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) for a total of 4 weeks or more prior to screening. Patients who received at least 2 NSAIDs for a total of 4 weeks or more without significant improvement in symptoms as evaluated by the investigator or who were intolerant; if Patients receiving salazosulfapyridine and\u002For methotrexate should have been on treatment for at least 3 months or longer and on a stable dose for at least 4 weeks or more prior to enrollment. If the patient is receiving salazosulfapyridine and\u002For methotrexate, the length of treatment prior to enrollment should be at least 3 months and longer and the stable dose at least 4 weeks and longer;\n* If the patient is receiving glucocorticosteroid therapy, stabilization for at least 4 weeks prior to enrollment to a dose equivalent to ≤ 10 mg of prednisone\u002Fday;\n* Patients and spouses who do not plan to have children within 1 week prior to screening and within 6 months after the end of the trial and who agree to to use effective non-pharmacological contraception during the trial;\n* Patients voluntarily signed an informed consent form and were willing to cooperate with the trial process.\n\nNote: CT findings may be accepted if the diagnosis is not clear on x-ray.\n\nExclusion Criteria:\n\n* Those with complete spinal rigidity;\n* Those with hypersensitivity to known components of the test drug, or a history of severe allergy.\n* Persons with a history of any malignancy (except basal cell carcinoma of the skin, carcinoma in situ) within 5 years prior to dosing\n* Persons with a cardiovascular or cerebrovascular event (heart attack, ischemic or hemorrhagic stroke (except lacunar cerebral infarction), severe cardiac arrhythmia, deep vein thrombosis, etc.) within 3 months prior to dosing\n* Those who have had a serious infection or have an active infection requiring intravenous antibiotic treatment within 4 weeks prior to screening\n* Lactating females or females with positive blood pregnancy test results at screening\u002Fbaseline\n* Persons with known human immunodeficiency virus infection or impaired immune function or infectious disease (e.g. HBsAg positive, HBcAb positive with HBV-DNA titer \\> 1000 IU\u002Fml, HCV-Ab, HIV-Ab, syphilis test (TRUST), tuberculosis test (T-SPOT.TB) positive);\n* Patients who have participated in other clinical trials or studies within 2 months prior to dosing;\n* Those who have been treated with TNF-alpha antagonists or other biological agents within 3 months prior to dosing\n* Those who have received DMARDs class drugs within 1 month prior to dosing (except for those treated with salazosulfapyridine or methotrexate for 3 months or more prior to screening and at a stable dose for at least 4 weeks or more) with leflunomide discontinuation \\\u003C8 weeks; or those with discontinuation time \\\u003C7 drug half-lives depending on the actual drug class (i.e. DMARDs class drug elution period should exceed 7 half-lives of the corresponding drug), whichever is longer;\n* Those whose screening or baseline phase examination meets any of the following: Glutamic aminotransferase (AST) or glutamic alanine aminotransferase (ALT) \\> 2.5 x ULN (non-hepatic source excluded); Serum creatinine \\> 1.5 x ULN or glomerular filtration rate a \\\u003C 60 mL\u002Fmin\u002F1.73 m2; Activated partial thromboplastin time (APTT) \\>1.5×ULN or prothrombin time (PT) \\> 2.5 x ULN (not receiving anticoagulation); Left ventricular ejection fraction ≤ 45%.\n* Previously treated with stem cell therapy;\n* Subjects with any other irreversible condition or symptom with an expected survival of \\\u003C3 months\n* Those who have undergone spinal or joint surgery within 2 months prior to dosing;\n* History of alcoholism, mental illness, drug abuse, or use of any drug within 12 months prior to administration;\n* Any other condition that, in the judgment of the investigator, makes them unsuitable for participation in this trial.","ALL","18 Years","65 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Ankylosing Spondylitis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Ankylosing Spondylitis in the future.\n\nParticipants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.",[27],"Ankylosing Spondylitis",[29,30],"Human umbilical cord mesenchymal stem cell","ankylosing spondylitis","NOT_YET_RECRUITING","2023-08-13",{"date":34,"type":35},"2023-08-15","ACTUAL",{"date":37,"type":21},"2023-08-30",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"Asia Cell Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100514832","phase-1-safety-and-tolerance-of-umbilical-cord-mesenchymal-stem-cells-in-patients-with-acute-respiratory-distress-syndrome-100514832","NCT05983627","Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Respiratory Distress Syndrome","A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of aCell Inj. of Allogeneic UC-MSCs in Patients With Mild to Moderate Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* 18-75 years old (including the threshold), male or female\n* A definite diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) (according to the ARDS Berlin definition and diagnostic criteria)\n* ARDS onset ≤ 5 days\n* 100 mmHg \\\u003C PaO2\u002FFiO2 ≤ 300 mmHg\n* Bilateral pulmonary infiltrates on chest radiograph or chest CT\n* Rule out other causes of pulmonary oedema, such as cardiogenic pulmonary oedema and pulmonary oedema due to fluid overload\n* Have no plans to have children within 2 weeks before screening and 3 months after the end of the trial, and agree to use effective non-pharmacological contraception during the trial\n* Patients voluntarily signed an informed consent form and were willing to co-operate with the trial process\n\nExclusion Criteria:\n\n* Hypersensitivity to known components of the drug (the main component of this product is human umbilical cord mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin, compound electrolyte injection), the presence of a history of allergy to gentamicin or other history of severe allergy\n* Patients requiring treatment for any malignancy within 2 years prior to administration (except non-melanoma skin cancer)\n* Lung transplant patients\n* Patients with malignant haematological diseases\n* Persons who have had a cardiovascular event within 3 months prior to dosing (e.g., unstable angina, congestive heart failure, myocardial infarction within the last 12 months, haemodynamic instability or known left ventricular ejection fraction (LVEF) \\\u003C40% or clinically significant rhythm or conduction abnormalities)\n* A history of deep vein thrombosis or pulmonary embolism during the Screening Period that, in the judgement of the Investigator, may be triggered or increase risk by receiving MSC transplantation therapy\n* A breastfeeding female or a female with a positive blood pregnancy test result during the Screening Period\n* History of immunodeficiency and\u002For autoimmune disease such as systemic lupus erythematosus (SLE), or other congenital immunodeficiency disease, idiopathic IgA deficiency. Laboratory tests at screening meet any of the following: Albuminous transaminase (AST) or albuminous transaminase (ALT) \\> 5 x ULN (non-hepatic sources are excluded; Serum creatinine \\> 1.5 x ULN or glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.74 m2; Activated partial thromboplastin time (APTT) \\> 2.5 x ULN or prothrombin time; (PT) \\> 2.5 x ULN (not receiving anticoagulation)\n* Positive infectious diseases (HBsAg, HCV, HIV-1, syphilis, active tuberculosis)\n* Currently receiving extracorporeal life support (ECLS) such as continuous haemodialysis (CRRT) and carbon dioxide removal (ECCO2R), or high frequency oscillatory ventilation (HFOV)\n* Presence of any other irreversible condition or symptom for which the subject has an expected survival of \\\u003C3 months\n* Combined WHO Class III or IV pulmonary hypertension\n* Patients who refuse lung protective ventilation and fluid management\n* Participation in other clinical trials or studies within 3 months prior to administration\n* Persons with prior stem cell therapy\n* Any other condition that, in the judgement of the investigator, makes participation in this trial inappropriate, such as a condition in which the study is not in the subject's current best interest (e.g., detrimental to health)","75 Years",{"count":20,"type":21},[24],"The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS), and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS).\n\nParticipants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells. Each subject will receive three infusions.",[55],"Acute Respiratory Distress Syndrome",[57,55],"Human Umbilical Cord Mesenchymal Stem Cells","2023-08-07",{"date":60,"type":35},"2023-08-09",{"date":37,"type":21},{"date":63,"type":21},"2026-12-31",{"name":41,"class":42},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":4},"100512171","phase-1-safety-of-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-patients-with-decompensated-hepatitis-b-cirrhosis-100512171","NCT05948982","Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis","A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of aCell Inj. of Allogeneic UC-MSCs in Patients With Decompensated Hepatitis B Cirrhosis","Inclusion Criteria:\n\n* 18 to 75 years old (including borderline values) at screening, regardless of gender\n* Diagnosed with decompensated hepatitis B cirrhosis according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)\n* There's no significant reduction in cirrhotic symptoms or no significant improvement in quality of life score after more than 3 months of strict medical conservative treatment\n* HBV DNA ≤ 1000 IU\u002FmL at the time of screening\n* Fully understand the informed consent form, voluntarily subject to the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease\n* Child-Pugh score \\>12;\n* History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;\n* Current serious medical conditions that would affect your safety and treatment efficacy assessment as determined by the investigator, such as: Class II or higher abnormal cardiac function (NYHA criteria), cardiovascular disease such as ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting glucose ≥ 10 mmol\u002FL or glycated hemoglobin (HbA1c) ≥ 8%), serum creatinine \\> 2 times the upper limit of normal (ULN), etc;\n* Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant upper gastrointestinal hemorrhage event within 4 weeks prior to screening), as determined by the investigator to be unsuitable for participation in this trial;\n* Have had hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening\n* Spontaneous peritonitis or a more severe active infection within 2 weeks prior to the trial\n* Positive infectious disease test (serum anti-HIV antibody, anti-HCV antibody, syphilis antibody either positive) or active tuberculosis;\n* Those who have received human albumin within 3 weeks prior to the first infusion of the test drug;\n* Those who have the history of venous thrombosis or pulmonary embolism\n* Drug addicted or alcohol abusers;\n* Women who are pregnant or breastfeeding;\n* Persons with a history of severe drug allergy or hypersensitivity;\n* History of a serious mental disorder, including uncontrolled major depression or controlled or uncontrolled psychosis, within 24 months prior to screening;\n* Those who have participated in other interventional clinical trials within 3 months prior to screening or are participating in other interventional clinical trials, or who have received prior stem cell therapy\n* Those who are proposed for liver transplantation within 3 months;\n* Other conditions that, in the opinion of the investigator, are not suitable for participation in this clinical trial.",{"count":73,"type":21},18,[24,75],"PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future.\n\nParticipants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.",[78],"Decompensated Liver Cirrhosis",[80,57],"Decompensated hepatitis B cirrhosis","2023-07-13",{"date":83,"type":35},"2023-07-17",{"date":85,"type":21},"2023-07-30",{"date":63,"type":21},{"name":41,"class":42},""]