[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hexun Biosciences Co., LTD.\",\"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,[8,44],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100604019","phase-1-safety-and-tolerability-study-of-mesenchymal-stem-cells-hexell-2020-in-elderly-subjects-with-mild-to-moderate-frailty-syndrome-100604019",false,"NCT07144072","Safety and Tolerability Study of Mesenchymal Stem Cells, HeXell-2020, in Elderly Subjects With Mild to Moderate Frailty Syndrome","A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of HeXell-2020 Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome","Inclusion Criteria:\n\nSubjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:\n\n1. Subjects aged ≥ 60 through ≤ 85 years old.\n2. Subjects with clinical diagnosis of mild to moderate Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to 6.\n3. Subject will not start any new treatment for this condition during the study.\n4. Subjects with body weight between 40 to 90 kg.\n5. Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.\n\nExclusion Criteria:\n\nSubjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:\n\n1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.\n2. Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.\n3. Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.\n4. Subjects who have a significant comorbid medical condition(s) including, but not limited to:\n\n   1. Severe kidney disease requiring hemodialysis or peritoneal dialysis;\n   2. Advanced liver disease such as severe liver cirrhosis;\n   3. Severe congestive heart failure (NYHA class 3 and 4);\n   4. Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)\n5. Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma or in situ carcinomas.\n6. Subjects using chronic immunosuppressant therapy, including corticosteroids (\\> 5 mg\u002Fday of prednisone, or equivalent), or TNF-alpha antagonists.\n7. Subjects on chronic immunosuppressive transplant therapy.\n8. Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.\n9. Subjects who have received any other stem cell therapy within 12 months prior to screening.\n10. Subjects with known allergy or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).\n11. Subjects who have a history of drug or alcohol abuse within the past 3 years.\n12. Subjects who are known to be infected with HIV.\n13. Subjects currently in hospital stay.\n14. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:\n\n    1. Psychiatric illness\n    2. Uncontrolled hypertension or hypotension\n    3. Unstable cardiac arrhythmia\n    4. Active Hepatitis B, Hepatitis C infections\n15. Subjects who have any condition that in the opinion of the Principal Investigator limits lifespan to \\\u003C 1 year.\n16. Subjects who have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.","ALL","60 Years","85 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome.\n\nHeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.",[27],"Frailty in Older Adults",[29,30,31],"HeXell-2020","Mesenchymal Stem Cells (MSC)","Frailty Syndrome (FS)","NOT_YET_RECRUITING","2025-08-28",{"date":35,"type":36},"2025-09-04","ACTUAL",{"date":38,"type":21},"2026-01-31",{"date":40,"type":21},"2028-07-31",{"name":42,"class":43},"Hexun Biosciences Co., LTD.","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":4},"100603483","phase-1-safety-and-preliminary-effectiveness-study-of-mesenchymal-stem-cells-hexell-2020-in-patients-with-stable-coronary-artery-disease-100603483","NCT07137104","Safety and Preliminary Effectiveness Study of Mesenchymal Stem Cells, HeXell-2020, in Patients With Stable Coronary Artery Disease","A Phase I\u002FIIa Study to Investigate the Safety, Tolerability, and Preliminary Effectiveness of HeXell-2020 in Patients With Stable Coronary Artery Disease (CAD)","Inclusion Criteria:\n\n1. Subject who is able to understand the nature of this study and accepts to enter the study by signing written informed consent\n2. Male or female who are aged between 18 and 75 years old on date of consent\n3. Patient without LV thrombus or ventricular aneurysm documented by echocardiography at screening\n4. Patient having a diagnosis of CAD caused by ≥ 50% stenosis of at least 1 major or larger epicardial coronary artery (target vessel ≥ 2 mm in diameter without in-stent restenosis) documented by imaging studies within 12 months prior to the date of dosing. If the stenosis results are derived from CCTA, the examination time of CCTA should be at least 6 months prior to screening.\n5. Patient with Canadian Cardiovascular Society (CCS) Class I, II, or III angina pectoris and received optimal, stable, medical therapy (e.g., anticoagulants therapy, β-blockers, calcium channel blockers, nitrates, ranolazine) per country specific treatment guidelines for at least 4 weeks prior to the date of screening, if prescribed\n6. Patients with stable hemodynamic parameters and adequate pulmonary function, defined as systolic pressure ≥ 90 mmHg and \\\u003C 150 mmHg, and heart rate \\> 50\u002Fmin and \\\u003C110\u002Fmin on at least 2 consecutive readings, at screening and baseline (before dosing)\n7. Patient's medical history shows no history of organ or cell transplant rejection, or suspected contraindication to HeXell-2020 including the components (penicillin and streptomycin).\n8. Female subjects show negative pregnancy test results within 30 days prior to the first study treatment.\n9. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods shown below, during dosing and for at least 4 weeks after stopping study treatment.\n\n   1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n   2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n   3. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.\n   4. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):\n\n   d.1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception. Please refer to 8.2 Prohibited Treatments for detailed information.\n\n   d.2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps).\n\nExclusion Criteria:\n\n1. Subject had participated in investigational drug trials and took any investigational drugs within 28 days prior to the first treatment.\n2. Patient is schedule to \\[or has received within 180 days prior to Screening Visit\\] undergo the following coronary revascularization throughout the study period:\n\n   * Coronary artery bypass grafting (CABG)\n   * Valve repair\u002Freplacement\n   * Cardiac resynchronization therapy (CRT) device\n3. Patient is scheduled to undergo percutaneous coronary intervention (PCI) during the trial before screening.\n4. Patient with high-risk or unstable acute coronary syndrome (e.g., myocardial infarction), major cardiovascular surgery (e.g., coronary valve replacement, or aortic aneurysm surgery), stroke, transient ischemic attack (TIA), carotid surgery, pulmonary embolism, or deep venous thrombosis in past 90 days prior to the date of screening\n5. Patient with evidence of medical condition as follows,\n\n   * Acute cardiac decompensation\n   * Congenital heart disease\n   * Significantly uncorrected valvular heart disease\n   * Malignant arrhythmia in the absence of a defibrillator\n   * Severe pulmonary disease\n   * Essential thrombocytosis\n   * Anti-phospholipid syndrome\n   * Other hypercoagulable disorders (e.g., disseminated intravascular coagulation, Factor V Leiden)\n6. Patient with poorly controlled diabetes mellitus (HbA1c \\>8%) or a known history or present evidence of conditions that may affect study assessments (e.g., currently receiving chemotherapeutic or immunosuppressant agents, or have received prior radiation therapy to the chest)\n7. Patient carry history of malignancy of any organ system (other than curatively treated localized basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer) within 5 years prior to study entry.\n8. Subject had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.\n9. Evidence of inadequate hematopoietic, hepatic, and renal function as determined by any one of the following laboratory requirements:\n\n   * Hemoglobin \\\u003C8.5 mg\u002FdL\n   * Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m2 as calculated by the Modified in Diet in Renal Disease (MDRD) formula or requiring dialysis prior to study dosing.\n   * Total bilirubin \\>2× upper limit of normal (ULN)\n   * Alanine aminotransferase (ALT) \\>3× ULN\n10. Patient with HIV, active HBV, or active HCV infections\n11. Subject who is pregnant or lactating\n12. Subject with underlying medical, mental or psychological conditions that would impair the treatment compliance, unable to undergo study-required tests\u002Fscans for any reason, or in the opinion of the investigator would not permit to participate in the study","18 Years","75 Years",{"count":54,"type":21},39,[24,56],"PHASE2","This is a phase I\u002FIIa study to investigate the safety, tolerability, and preliminary effectiveness of HeXell-2020 in patients with stable coronary artery disease (CAD). HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.",[59],"Coronary Artery Disease",[29,61,30],"Coronary Artery Disease (CAD)","2025-08-15",{"date":64,"type":36},"2025-08-22",{"date":66,"type":21},"2025-12-01",{"date":40,"type":21},{"name":42,"class":43},""]