[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Wingor Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652601","phase-1-phase-a-trial-evaluating-intravenous-huc-mscs-injection-for-safety-tolerability-and-efficacy-in-patients-with-poi-100652601",false,"NCT07775391","Phase Ⅰ\u002FⅡa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI","Phase Ⅰ\u002FⅡa Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Injection of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in Patients With Premature Ovarian Insufficiency (POI)","Inclusion Criteria:\n\n1. Aged 18 to 40 years at the time of signing the informed consent form (exclusive of the boundary values);\n2. Meet the diagnostic criteria specified in the Expert Consensus on Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency (2023 Edition): oligomenorrhea (menstrual cycle longer than 35 days) or amenorrhea for more than 4 months, with basal serum follicle-stimulating hormone (FSH) \\> 25 U\u002FL (tested on Days 2-4 of the menstrual cycle or during amenorrhea, at least twice with an interval of ≥4 weeks);\n3. Satisfy one of the following two criteria:\n\n   1. Total number of antral follicles (AFC) with a diameter of 2-10 mm in bilateral ovaries \\\u003C 5;\n   2. Serum anti-Müllerian hormone (AMH) ≤ 7.85 pmol\u002FL (equivalent to 1.1 ng\u002FmL);\n4. Have received standardized hormone replacement therapy (HRT) at a stable dose for ≥3 months prior to drug administration with stable hormone levels, and maintain stable HRT per medical advice throughout the trial (within 24 weeks after enrollment);\n5. Have no fertility requirements;\n6. Agree to use effective contraceptive measures throughout the trial period (such as complete abstinence, condoms, cervical caps plus spermicides, intrauterine devices, etc.);\n7. Negative serum β-hCG test result during the screening period (to rule out pregnancy);\n8. Fully understand the trial information and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with primary amenorrhea;\n2. Subjects with thyroid disorders (hypothyroidism\u002Fhyperthyroidism or thyroid malignant tumors) or resistant ovary syndrome (ROS);\n3. Subjects with abnormal female karyotypes (e.g., Turner syndrome, Fragile X syndrome);\n4. Positive serology tests (HBV antibody, HCV antibody, HIV antibody, syphilis). Exceptions: HBV carriers, patients with stable HBV after drug treatment (HBV DNA titer ≤500 IU\u002FmL or copies \\\u003C1000 copies\u002FmL), and patients with cured HCV (negative HCV RNA test) may be enrolled if deemed eligible by the investigator;\n5. Subjects receiving or planning to use the following medications during the trial: oral or systemic corticosteroids, danazol, anticoagulants, Chinese herbal medicines or botanical supplements that may affect hormone levels or ovarian function;\n6. History of hypersensitivity to human serum albumin;\n7. Pregnant or breastfeeding subjects;\n8. Participation in another clinical trial within the past 3 months, or receipt of other cell therapies (excluding blood transfusion);\n9. History of malignant tumors;\n10. Subjects with contraindications or cautions for estrogen use, including known or suspected breast cancer, endometrial cancer, other known or suspected sex hormone-dependent malignancies, active venous or arterial thromboembolic diseases within the last 6 months, undiagnosed abnormal genital bleeding, severe hepatic or renal insufficiency \\[serum aspartate aminotransferase (AST) \\>3×ULN, serum alanine aminotransferase (ALT) \\>3×ULN, estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\\], etc.;\n11. Uncontrolled diabetes, hypertension (\\>150\u002F100 mmHg), heart disease, etc.;\n12. Any other conditions judged by the investigator to render the subject unsuitable for participation in this study.","FEMALE","18 Years","40 Years",{"count":20,"type":21},59,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase I\u002FIIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI).\n\nThe primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial.\n\nThe primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal\u002Fconfirmatory clinical trials.",[28],"Premature Ovarian Insufficiency",[30,31,28],"hUC-MSCs","POI","RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":36},"2026-08-03",{"date":40,"type":21},"2029-08-02",{"name":42,"class":43},"Shenzhen Wingor Biotechnology Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100599401","phase-2-a-phase-iia-clinical-trial-to-evaluate-the-efficacy-and-safety-of-intravenous-infusion-of-huc-mscs-in-patients-with-ais-100599401","NCT07084012","A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS","A Phase IIa Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in the Treatment of Acute Ischemic Stroke (AIS)","Inclusion Criteria:\n\n1. Age 18 to 75 years, inclusive, regardless of gender.\n2. Diagnosis of acute ischemic stroke (AIS).\n3. Onset time ≤ 72 hours.\n4. Anterior circulation cerebral infarction.\n5. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.\n6. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.\n7. The subject or their legal guardian has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Planned or already undergone thrombolysis or thrombectomy for this stroke.\n2. History of epilepsy (excluding secondary epilepsy that does not currently require medication), Parkinson's disease, Alzheimer's disease, severe depression, or other diseases that the investigator deems would affect the subject's participation in the trial or the assessment of efficacy.\n3. Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural\u002Fepidural hematoma, etc.). If only petechial bleeding is present, the investigator may determine whether the subject is suitable for inclusion in the study.\n4. Computed tomography (CT) or magnetic resonance imaging (MRI) of the head showing a large ischemic area in the middle cerebral artery territory or midline shift greater than 1 cm on head CT\u002FMRI, and the investigator assesses a high likelihood of surgical intervention or poor prognosis.\n5. Presence of brain tumor or history of malignancy.\n6. Liver or kidney insufficiency during the screening period: Aspartate aminotransferase (AST) \\> 2.5 × upper limit of normal, alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal, estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n7. History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial.\n8. Severe infection, including sepsis, septic shock, severe pneumonia, etc.\n9. Systemic corticosteroid ( \\> 10 mg\u002Fday prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial.\n10. History of alcohol abuse within the past year (defined as an average of more than 2 units per day (1 unit = 10 mL ethanol, i.e., 1 unit = 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol wine).\n11. Pregnant or breastfeeding women; or unwillingness to use reliable contraception (e.g., condoms) throughout the study period, or plans to donate sperm or eggs, or have plans for pregnancy.\n12. Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion).\n13. Other situations in which the investigator deems the patient unsuitable for participation in this study (including but not limited to non-compliance with the principle of patient benefit, poor patient compliance, unacceptable laboratory abnormalities, etc.).","ALL","75 Years",{"count":55,"type":21},60,[25],"This is a Phase IIa clinical trial with a three-arm design that utilizes randomization, double-blinding, and placebo control. The primary objective of this study is to evaluate the efficacy of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The secondary objective is to assess the safety and tolerability of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The exploratory objective is to investigate the pharmacokinetic and pharmacodynamic characteristics of hUC-MSCs injection in patients with AIS.",[59],"Acute Ischemic Stroke AIS",[30,61,62],"AIS,","Acute Ischemic Stroke","2026-07-27",{"date":65,"type":36},"2026-07-29",{"date":67,"type":36},"2025-08-27",{"date":69,"type":21},"2028-12-30",{"name":42,"class":43},""]