[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Baermed\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100565191","phase-1-clinical-utility-and-safety-of-human-umbilical-cord-mesenchymal-stem-cell-secretome-in-drug-resistant-epilepsy-single-center-non-randomized-phase-i-clinical-trial-100565191",false,"NCT06638970","Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial","Inclusion Criteria:\n\n* Individuals aged 18 to 60 years.\n* Individuals with a clinical diagnosis of epilepsy confirmed by a neurologist based on internationally accepted criteria.\n* Individuals with a seizure frequency of at least 6 times in 12 months.\n* Individuals who have a history of recurrent seizures that are not controlled with standard antiepileptic treatment of at least 2 types of drugs for at least 12 months.\n* Individuals who are in stable general health, without life-threatening acute illnesses or uncontrolled medical conditions.\n* Individuals who do not have a history of other neurodegenerative diseases or severe psychiatric disorders that could affect the results of the study.\n* Individuals who are not pregnant or breastfeeding.\n* Individuals who are willing to provide written consent after receiving complete information about the study.\n\nExclusion Criteria:\n\n* Individuals with a history of stroke or evidence of stroke on medical examination.\n* Individuals who have undergone surgery for the treatment of epilepsy.\n* Individuals with a history of allergy or hypersensitivity reactions to the secretome or related components.\n* Individuals with active or uncontrolled autoimmune disease.\n* Individuals receiving immunosuppressive therapy.\n* Individuals with severe hepatic or renal impairment.\n* Individuals with significant vascular or blood vessel disease.","ALL","18 Years","60 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are:\n\n1. How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group?\n2. How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?\n3. How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group?\n4. How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group?\n5. How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?\n6. How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?",[26,27],"Epilepsy","Drugs Resistant Epilepsy",[29,30,31,32,33],"secretome","stem cells","epilepsy","drug resistant epilepsy","qEEG","NOT_YET_RECRUITING","2024-10-10",{"date":37,"type":38},"2024-10-15","ACTUAL",{"date":40,"type":20},"2024-12-01",{"date":42,"type":20},"2026-10-31",{"name":44,"class":45},"Baermed","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100564691","phase-1-clinical-utility-and-safety-of-human-umbilical-cord-mesenchymal-stem-cell-secretome-in-moderate-neurocognitive-impairment-dementia-100564691","NCT06632470","Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)","Inclusion Criteria:\n\n1. Age \\> 60 years old\n2. Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10\n3. Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment\n4. Patient is in stable condition without life threatening disease or uncontrolled medical condition\n5. Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial\n6. Patient with care giver or supporting family who can assist patient with research protocol\n\nExclusion Criteria:\n\n1. Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse\n2. Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection\n3. Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder\n4. Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial\n5. Patient who has allergy or hypersensitivity reaction towards secretome\n6. Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications\n7. Patient is unable to provide written informed consent and not capable to understand and comply to research protocol\n8. Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule",{"count":19,"type":20},[23],"The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are:\n\n1. Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia?\n2. How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia?\n3. What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored)\n\nParticipants will\n\n* Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months\n* Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination",[57,58],"Dementia","Moderate Dementia",[60,61,62,29,63,30],"dementia","moderate dementia","neurocognitive impairment","HUCSMC","2024-10-07",{"date":66,"type":38},"2024-10-09",{"date":37,"type":20},{"date":69,"type":20},"2025-10-01",{"name":44,"class":45},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":92,"locationsCount":46},"100564494","phase-1-safety-and-feasibility-of-human-umbilical-cord-mesenchymal-stem-cell-derived-secretome-in-the-treatment-of-liver-cirrhosis-a-comprehensive-evaluation-of-fibrosis-reduction-immunomodulation-and-hepatic-regeneration-a-single-center-randomized-phase-i-clinical-trial-100564494","NCT06629909","Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration: a Single Center, Randomized, Phase I Clinical Trial","Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration a Single Center, Non-randomized, Phase I Clinical Trial","Inclusion Criteria:\n\n* Age above 17 years, both men and women\n* Patient is willing to participate and sign informed consent\n* Patient is diagnosed with liver cirrhosis confirmed by clinical examination and diagnostic imaging\n* Liver cirrhosis patient with Child-Pugh Class B\n* Patient is in a stable condition without life threatening complications such as active gastrointestinal bleeding, severe infection, severe renal failure (eGFR\\&amp\\>30) at time of registration\n* Patient is not receiving experimental drugs for liver cirrhosis for the past 6 months\n* Patient is able and willing to comply with research protocol including follow up visits and evaluations\n\nExclusion Criteria:\n\n* Patient with uncontrolled psychiatric disorders\n* Patient who is diagnosed with hepatic or non- hepatic malignancy\n* Lactating and pregnant patient\n* Patient who has allergy or hypersensitivity reaction towards secretome","17 Years",{"count":19,"type":20},[23],"The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:\n\n1. How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?\n2. How effective is secretome injection in liver fibrosis 6 months after injection?\n3. Does secretome injection improve liver function after 6 months after Injection?\n4. Does secretome injection affect Child Turcotte Pugh score?\n5. How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?\n6. How does secretome injection affect the quality of life in live cirrhosis patient?\n7. What is the relationship between secretome injection and encephalopathy? Researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid)\n\nResearchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)\n\nPatients will:\n\nBe injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.\n\nVisit the clinic once every two weeks to receive drugs and treatment for 4 months.\n\nFollow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)",[83],"Liver Cirrhosis",[85,29,30,86],"liver cirrhosis","HUCMSC","2024-10-04",{"date":89,"type":38},"2024-10-08",{"date":40,"type":20},{"date":42,"type":20},{"name":44,"class":45},""]