[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Engineering Center of Cell Products\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100584097","phase-2-umbilical-cord-derived-mesenchymal-stem-cell-infusion-for-treating-aclf-100584097",false,"NCT06884904","Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF","Umbilical Mesenchymal Stem Cells in the Treatment of Acute-on-Chronic Liver Failure：A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIb\u002FIII Seamless Adaptive Design Clinical Study","MSCTACLF","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.\n2. Patients with hepatitis B virus (HBV)-associated acute-on-chronic liver failure (ACLF) meeting the following criteria: Total bilirubin (TBil) ≥12 mg\u002FdL (equivalent to 205 μmol\u002FL); International normalized ratio (INR) ≥1.5 or prothrombin activity (PTA) ≤40%;\n3. All participants and their partners agree to use effective non-pharmacological contraception during the trial and for 6 months after trial completion, with no plans for conception during this period.\n4. Voluntarily participate in the clinical study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of allergy to any component of the investigational drug or bovine-derived products.\n2. Acute, subacute, or chronic liver failure unrelated to HBV, or ACLF caused by: Concurrent hepatitis A, C, or E virus infection; Autoimmune liver disease; Biliary obstruction.\n3. Presence of any of the following complications: \\\u003C1\\> Active gastrointestinal bleeding (e.g., hematemesis and\u002For melena) or high- risk esophageal\u002Fgastric varices (confirmed by endoscopy or imaging within 3 months prior to screening). \\\u003C2\\> Imaging evidence (ultrasound or CT) of cavernous transformation of the portal vein or portal vein occlusion. \\\u003C3\\> History of transjugular intrahepatic portosystemic shunt (TIPS). \\\u003C4\\> Grade 3 or 4 hepatic encephalopathy. \\\u003C5\\> Serum creatinine ≥2 mg\u002FdL. \\\u003C6\\> Respiratory insufficiency (e.g., dyspnea, cyanosis) with peripheral oxygen saturation ≤93% at rest.\n4. Severe underlying diseases, including: \\\u003C1\\>Septic shock (requiring vasopressors to maintain mean arterial pressure ≥65 mmHg despite adequate fluid resuscitation, with blood lactate \\>2 mmol\u002FL). \\\u003C2\\> Uncontrolled cardiac conditions: Myocardial ischemia or infarction (CTCAE v5.0 Grade ≥II), Arrhythmias requiring intervention, NYHA Class III-IV heart failure. \\\u003C3\\> Active malignancy (solid or hematologic). \\\u003C4\\> Diagnosed pulmonary hypertension or suspected pulmonary embolism. \\\u003C5\\> IgA deficiency, Henoch-Schönlein purpura, hemophilia, or idiopathic thrombocytopenia. \\\u003C6\\> Immunodeficiency disorders (e.g., HIV infection, congenital\u002Facquired immune deficiency).\n5. Current systemic corticosteroid therapy for other diseases.\n6. Psychiatric or other conditions deemed by the investigator to interfere with study assessments.\n7. Planned or active registration for liver transplantation, or anticipated transplantation within 3 months.\n8. History of liver transplantation.\n9. Alcohol or substance abuse: Chronic alcohol use (\\>5 years with ethanol intake ≥40 g\u002Fday for males or ≥20 g\u002Fday for females), Heavy alcohol use (\\>80 g\u002Fday ethanol) within 2 weeks prior to screening, Abstinence \\\u003C6 months.\n10. Participation in another clinical trial within 3 months prior to screening (excluding screen failures or withdrawal before dosing).\n11. Pregnancy, lactation, or positive pregnancy test at screening.\n12. Any other condition that, in the investigator's judgment, may confound study results, pose risks, or compromise the participant's best interests.","ALL","18 Years","70 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled adaptive design Phase IIb\u002FIII clinical trial. It employs a seamless adaptive design, divided into Phase IIb and Phase III, focusing on patients with acute-on-chronic liver failure (ACLF). Eligible patients meeting the inclusion criteria and not disqualified were randomized in a 2:2:1:1 ratio during Phase IIb to receive either a high-dose experimental group (4.0×10\\^6\u002Fkg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.0×10\\^6\u002Fkg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.0×10\\^6\u002Fkg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.0×10\\^6\u002Fkg). In Phase III, patients were randomized in a 1:1 ratio to the experimental group (injectable umbilical cord-derived mesenchymal stem cells) or the control group. All groups received standard treatment alongside either the experimental drug (experimental group) or placebo (control group) to evaluate and confirm the efficacy and safety of injectable umbilical cord-derived mesenchymal stem cells in treating acute-on-chronic liver failure.",[29],"Acute-On-Chronic Liver Failure",[31,32],"acute-on-chronic liver failure","mesenchymal stem cells","NOT_YET_RECRUITING","2025-03-13",{"date":36,"type":37},"2025-03-19","ACTUAL",{"date":39,"type":22},"2025-04-15",{"date":41,"type":22},"2028-04-14",{"name":43,"class":44},"National Engineering Center of Cell Products","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100555962","phase-1-umbilical-cord-derived-mesenchymal-stem-cell-infusion-for-treating-acute-ischemic-stroke-100555962","NCT06518902","Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating Acute Ischemic Stroke","A Single Arm, Open Label Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Mesenchymal Stem Cells (Umbilical Cord) Injection in the Treatment of Acute Ischemic Stroke (AIS) Patients","UMERIS","Inclusion Criteria:\n\n1. Age range of 18-80 years old (including threshold), gender not limited;\n2. The clinical diagnosis of this episode is anterior circulation ischemic stroke, confirmed by MRI\u002FCT, and the patient can receive experimental drugs within one month after the onset of stroke symptoms;\n3. Individuals with a National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive) and a NIHSS score of Ia\\\u003C2 points;\n4. Female subjects with fertility or male subjects with fertility partners who have no fertility plans and voluntarily take effective contraceptive measures during the study period;\n5. Individuals with self-reported or family reported mRS scores of 0 or 1 prior to the onset of current stroke symptoms;\n6. After receiving complete information about the study, all participants voluntarily participate in the clinical study by signing an informed consent form themselves or their guardians.\n\nExclusion Criteria:\n\n1. Individuals with epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological disorders or mental illnesses that researchers believe may affect their ability to participate in trials or impact research evaluations;\n2. Bleeding transformation occurred, and according to the researchers' judgment, it is not suitable to participate in clinical trials;\n3. Patients with malignant tumors, excluding low-grade malignant tumors such as basal cell carcinoma, papillary thyroid carcinoma, and localized prostate cancer in situ, who have received curative treatment for more than five years;\n4. Serious infections, including sepsis, septic shock, severe pneumonia (diagnostic criteria for severe pneumonia refer to the 2007 American College of Infectious Diseases\u002FAmerican Thoracic Society diagnostic criteria for adult severe pneumonia), etc;\n5. Patients with respiratory failure, or those with current evidence of pulmonary embolism or suspected pulmonary embolism;\n6. Organ function levels that meet any one or more of the following criteria:\n\n   1. ALT or AST\\>2 × ULN; TBil\\>1.5×ULN； Scr\\>2×ULN；\n   2. Thrombocytopenia (platelet count\\\u003C75000\u002Fmm3) or heparin induced thrombocytopenia;\n   3. For patients who have not received anticoagulant therapy, activated partial thromboplastin time (APTT)\\>2.5 × ULN or prothrombin time (PT)\\>2.5 × ULN; Patients who have received anticoagulant therapy and have been assessed by researchers to have a serious risk of bleeding;\n   4. Hemoglobin (Hb)\\\u003C90g\u002FL;\n7. Individuals who have had or currently have severe cardiovascular disease:\n\n   1. Suffering from CTCAE grade II or above myocardial ischemia or myocardial infarction, or unstable angina pectoris;\n   2. Researchers believe that severe arrhythmias with clinical significance;\n   3. NYHA standard III-IV cardiac dysfunction;\n   4. Other acute and severe complications that endanger life;\n8. Poorly controlled hypertensive patients (defined as those who have undergone antihypertensive treatment but have sustained systolic blood pressure\\>220mmHg or diastolic blood pressure\\>120mmHg);\n9. Poorly controlled diabetes (defined as blood glucose still\\>16.8 mmol\u002FL after treatment) or hypoglycemia (blood glucose\\\u003C2.8 mmol\u002FL);\n10. Individuals with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, idiopathic IgA deficiency, or those who require systemic steroid hormone (≥ 10 mg\u002Fday of prednisone equivalent)\u002Fimmunosuppressive drug treatment within 14 days prior to or during the trial period;\n11. Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), as well as positive for HBV DNA, hepatitis C antibody (HCV), or Treponema pallidum antibody (TPAb\u002FPRR);\n12. Screening individuals who have participated in clinical trials of other drugs within the previous 3 months;\n13. Individuals known to be allergic to the investigational drug or any component of the investigational drug (including human serum albumin, dimethyl sulfoxide, or compound electrolyte injection, as well as bovine derived products);\n14. Individuals who are unable to undergo cranial CT\u002FMRI examination due to various reasons;\n15. Patients who have undergone major surgery, suffered severe trauma, or plan to undergo neurological function assessment during the trial period within the 3 months prior to the first administration of medication;\n16. Breastfeeding or pregnant women (pregnancy diagnosis is evaluated through a combination of blood pregnancy test\u002Furine pregnancy test and\u002For obstetric ultrasound examination);\n17. Combining other serious systemic diseases, or having a medical history of any disease or laboratory abnormality that may confuse the study results, interfere with subject participation in the study procedure, or not be in the best interest of subject participation in the study, based on the researcher's judgment, is not suitable for inclusion.","80 Years",{"count":55,"type":22},18,[57],"PHASE1","The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . The main questions it aims to answer are:\n\nIdentify the dose-limiting toxicity (DLT) of drug mesenchymal stem cells (umbilical cord) injection in acute ischemic stroke patients.\n\nDose the drug mesenchymal stem cells (umbilical cord) injection improves the mRS score, NIHSS score, Fugl-Meyer score and and Barthel index of acute ischemic stroke patients? What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.\n\nWhat is the the possible molecular mechanisms of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.\n\nParticipants will:\n\nTake drug drug mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks.\n\nAfter receiving the corresponding dose of mesenchymal stem cells (umbilical cord) injection, the subjects entered a 6-month safety, efficacy observation and further safety evaluation period. Long term efficacy and survival follow-up up to 2 years.",[60],"Acute Ischemic Stroke","2024-07-19",{"date":63,"type":37},"2024-07-25",{"date":65,"type":22},"2024-08",{"date":67,"type":22},"2025-12",{"name":43,"class":44},""]