[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vinmec Research Institute of Stem Cell and Gene Technology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,93,121],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100629253","phase-1-safety-evaluation-of-msc-based-therapy-for-liver-cihcrosis-treatment-100629253",false,"NCT07472270","Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment","Phase 1 Clinical Trial: Evaluation of the Safety and Preliminary Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Extracellular Vesicle Therapy in the Treatment of Liver Cirrhosis","Inclusion Criteria:\n\n* Liver cirrhosis due to alcohol-related liver disease or chronic hepatitis B or C\n* Child-Pugh score 7-12\n* Alcohol-related cirrhosis: abstinent from alcohol ≥ 3 months\n* HBV\u002FHCV-related cirrhosis: viral disease controlled according to standard clinical criteria\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Significant renal dysfunction or coagulation abnormalities\n* Liver cirrhosis of unknown etiology\n* Current or suspected hepatocellular carcinoma or history of malignancy\n* Portal vein thrombosis\n* Pregnancy, breastfeeding, or inadequate contraception\n* Severe renal, respiratory, cardiovascular, infectious, autoimmune, metabolic, or neurological disorders that may interfere with study participation\n* Refractory ascites at screening\n* Use of known hepatotoxic medications within a clinically relevant period\n* Coinfection with HIV, tuberculosis, or other causes of chronic liver disease","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. The trial uses a rolling six dose-escalation design, enrolling up to 12 adult patients (18-75 years) with Child-Pugh scores of 7-12.\n\nThe results of this study are expected to provide initial clinical evidence supporting the safety and potential therapeutic role of UC-MSC-EVs as a novel cell-free treatment approach for liver cirrhosis.",[27],"Liver Cirrhosis","NOT_YET_RECRUITING","2026-03-13",{"date":31,"type":32},"2026-03-16","ACTUAL",{"date":34,"type":21},"2026-03-15",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Vinmec Research Institute of Stem Cell and Gene Technology","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100626184","phase-1-cd19-car-t-cell-therapy-for-refractory-systemic-lupus-erythematosus-100626184","NCT07432334","CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus","Evaluation of the Safety and Efficacy of CD19 CAR T-Cell Therapy for the Treatment of Refractory Systemic Lupus Erythematosus: A Phase I Clinical Trial","Inclusion Criteria:\n\n* Age 16 to 55 years, male or female\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria with a total score ≥ 10\n* SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)\n* Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history\n\nRefractory systemic lupus erythematosus or refractory lupus nephritis defined as one of the following:\n\nRefractory SLE:\n\n\\- Failure to achieve adequate response, partial response, or stable disease control after ≥ 6 months of standard-of-care therapy (documented compliance). Standard therapy includes corticosteroids plus hydroxychloroquine and at least two of the following: calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, azathioprine, or B-cell-targeted therapy (e.g., rituximab, belimumab).\n\nRefractory Lupus Nephritis:\n\n* Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6 months (with or without calcineurin inhibitors, rituximab, or belimumab), AND:\n* Histopathologic confirmation of Class III or Class IV lupus nephritis, with or without Class V (ISN\u002FRPS 2003 classification); isolated Class V is excluded\n* Proteinuria \\> 1 g\u002F24 hours OR urine protein-to-creatinine ratio \\> 1 mg\u002Fmg\n* Adequate organ function:\n\n  * ALT ≤ 5 × upper limit of normal; total bilirubin ≤ 34 μmol\u002FL (≤ 2.0 mg\u002FdL)\n  * Pulmonary function: FVC ≥ 60% predicted OR FEV1 ≥ 60% predicted\n  * Cardiac function: LVEF ≥ 50%, no uncontrolled arrhythmia, no intracardiac thrombus, no heart failure\n* Adequate hematologic parameters:\n\n  * Absolute neutrophil count ≥ 0.8 × 10⁹\u002FL (without growth factor support)\n  * Absolute lymphocyte count ≥ 0.3 × 10⁹\u002FL\n  * Platelet count ≥ 50 × 10⁹\u002FL\n  * Hemoglobin ≥ 80 g\u002FL (≥ 8.0 g\u002FdL)\n* Ability to provide written informed consent\n* Agreement to use effective contraception during the study period (for participants of reproductive potential)\n\nExclusion Criteria:\n\n* History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)\n* Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)\n* Prior kidney transplantation\n* Severe asthma requiring long-term treatment or respiratory failure\n* Severe hemolytic anemia requiring transfusion at intervals ≤ 7 days\n* Active viral infections (e.g., hepatitis B or C, HIV, tuberculosis, malaria, syphilis, CMV, EBV) or other life-threatening infectious diseases\n* Active bacterial infection confirmed by clinical evaluation, imaging, or laboratory testing\n* Use of the following prior to leukapheresis:\n\n  * Anti-CD20 therapy, cyclophosphamide, live or attenuated vaccines within 1 month\n  * Systemic corticosteroids \\> 10 mg\u002Fday (prednisone equivalent), T-cell-targeted therapy (e.g., mycophenolate mofetil, calcineurin inhibitors), immunosuppressive agents, or antimalarial agents within 7 days\n  * Prior anti-CD19 therapy\n  * Prior T-cell-based cellular therapy or gene therapy, including CAR-T therapy\n* Current or prior malignancy\n* Known hypersensitivity to study-related agents\n* Pregnant or breastfeeding women\n* Active antiphospholipid syndrome (stable antiphospholipid antibody positivity without active APS is permitted)\n* Participation in another clinical trial at the time of screening\n* Any condition that, in the investigator's judgment, would interfere with protocol compliance or study participation","16 Years","55 Years",{"count":51,"type":21},8,[24],"The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments.\n\nThe primary questions this study aims to address are:\n\nWhat is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group.\n\nParticipants will:\n\nUndergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters",[55],"Refractory Systemic Lupus Erythematosus",[57,58],"CD19 CAR-T","Autoimmune Disease","2026-02-24",{"date":61,"type":32},"2026-02-25",{"date":63,"type":21},"2026-03-01",{"date":65,"type":21},"2027-11",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100564449","phase-2-evaluating-bone-marrow-cell-transplant-for-treating-cerebral-palsy-from-brain-hypoxia-100564449","NCT06629324","Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia","Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial","Inclusion Criteria:\n\n* Age from 1 to 10 years, both genders;\n* Gross Motor Function Classification System (GMFCS): levels II to V;\n* Spastic cerebral palsy due to brain hypoxia.\n\nExclusion Criteria:\n\n* Coagulation disorders;\n* Severe health conditions such as cachexia, heart failure, lung, liver, or kidney failure; or active infections;\n* Spinal injuries prevent the placement of a catheter through the spinal cavity;\n* Cancer;\n* HIV positive, active viral hepatitis;\n* Hemoglobin below 110 g\u002FL.","1 Year","10 Years",{"count":77,"type":21},58,[79],"PHASE2","This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.\n\nThe key questions the study seeks to answer are:\n\n* What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation?\n* How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy?\n* How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS\u002FMini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation?\n\nFifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups:\n\n* Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route.\n* Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline.\n* Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).",[82],"Autism Spectrum Disorder","RECRUITING","2026-01-20",{"date":86,"type":32},"2026-01-22",{"date":88,"type":32},"2024-10-15",{"date":90,"type":21},"2027-01-31",{"name":38,"class":39},2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":40},"100464589","phase-2-adipose-tissue-derived-mesenchymal-stem-cell-ad-msc-therapy-for-the-treatment-of-sexual-function-impairment-in-female-100464589","NCT05329662","Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female","Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female","Inclusion Criteria:\n\n* Women who are 40 - 50 years of age or older and have not gone through menopause according to Stages of Reproductive Aging Workshop (STRAW) 2011\n* The last menstrual period before participating in the study at least 2 months or more\n* FSH, Estrogen above the menopause:\n* \\+ FSH \\> 40 mIU\u002FmL\n* \\+ Estradiol \\\u003C 30 pg\u002FmL\n* (tested between the 2nd and the 4th day of the menstrual cycle)\n* FSFI \\\u003C 26.55 ± signs of decline in sexual or reproductive functions such as symptoms of premenopausal such as hot flashes, excessive sweating, headaches\n* Normal liver function\n* Normal kidney function\n* Normal cardiovascular function\n* No active bacterial, fungal and viral (HIV, HBV, HCV, syphilis) infections\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Previous surgery to remove gonads\n* No sexual activity\n* Diagnosed with cancer and is being or has not been treated\n* Had an organ transplant\n* Has congenital malformations related to the gonads\n* Chronic disease such as: Diabetes, hypopituitarism, adrenal insufficiency, blood pressure unresponsive to treatment, etc\n* Any active autoimmune diseases\n* Being diagnosed with heart failure, kidney failure, liver failure, respiratory failure, history of cerebral infarction, myocardial infarction, Alzheimer's\n* Hypothyroidism or hyperthyroidism\n* Any active autoimmune diseases\n* Any clinically significant blood coagulation disorders.\n* History of allergic reaction to anesthetic agents and antibiotics\n* Using hormone therapy within the last 2 weeks or want to use these drugs during the study period\n* Planning to become pregnant during the study period\n* using hormonal contraceptives\n* Absence of menstruation for at least 12 months\n* Mental illness, inability to communicate, inability to answer the interview questions correctly","FEMALE","40 Years","65 Years",{"count":104,"type":21},130,[79],"Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10\\^6 cells\u002Fkg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.",[108],"Sexual Dysfunction Female",[110,111,112],"sexual dysfunction Female","adipose mesenchymal stem cell","reproductive hormones","2024-06-03",{"date":115,"type":32},"2024-06-04",{"date":117,"type":32},"2023-05-01",{"date":119,"type":21},"2025-12-30",{"name":38,"class":39},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":143,"locationsCount":40},"100465799","phase-1-umbilical-cord-derived-mesenchymal-stem-cell-vcell-1-for-male-patients-with-sexual-deficiency-100465799","NCT05345418","Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency","Evaluation of the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency: A Phase I\u002FIIa Randomised Crossover Trial","Inclusion Criteria:\n\n* Males with sexual hormone deficiency aged 50 to 70 years\n* AMS score ≥ 27\n* IIEF \\\u003C 14\n* SQoL-M ≤ 87\n* and Testosterone ≤ 12 nMol\u002FL\n* Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).\n* Normal kidney function is usually according to the biological index of Vietnamese people.\n* No infection, HIV, HBV, active syphilis.\n* Must provide written informed consent.\n\nExclusion Criteria:\n\n* The patient had surgery to remove the gonads.\n* Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test.\n\nThe patient is taking anti-rejection drugs.\n\n* Patients with malformations, malformations or tumors of the endocrine glands.\n* Endocrine impairment due to diabetes (HBA1c \\> 7) and other metabolic diseases.\n* Patients with active autoimmune disease or positive for antinuclear antibodies.\n* Patients with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.\n* Patients with hypothyroidism.\n* The patient has an acute infection.\n* Patients with clinically significant coagulopathy or other hematological diseases.\n* History of allergy to anesthetics, anesthetics, antibiotics.\n* Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.\n* The patient is a smoker.","MALE","50 Years","70 Years",{"count":132,"type":21},158,[24,79],"Sexual functional deficiency affects largely the physical conditions, life and sexual quality of the patients. Hypogonadism affects about 4 to 5 million men in the US, and the incidence increases with age. In our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency.",[136],"Sexual Dysfunction Male",[136,112,138],"mesenchymal stem Cell",{"date":115,"type":32},{"date":141,"type":32},"2022-04-01",{"date":119,"type":21},{"name":38,"class":39},""]