[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465799":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Vinmec Research Institute of Stem Cell and Gene Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Umbilical Cord-Derived Mesenchymal Stem Cell, then Placebo (group A)","EXPERIMENTAL","Cohort 1 will receive two single intravenous dose of UC MSCs of 1.5 million cells per kilogram body weight on their Study Month 0, and Study Month 3.\n\n\\- Each treatment period was separated by a 4 - week washout to allow the effective systemic elimination of the UC MSCs before subsequent treatment initiation",[13],"Biological: Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo, then Umbilical Cord-Derived Mesenchymal Stem Cell (group B)","ACTIVE_COMPARATOR","Cohort 2 will receive two single intravenous dose of UC MSCs of 1.5 million cells per kilogram body weight on their Study Month 7, and Study Month 10",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency","Patients will receive two administrations at a dose of 1.5 million cells\u002Fkg patient bodyweight via the IV route with a 3-month intervening interval. A validated umbilical cord blood mesenchymal stem cells (UC-MSC) line was selected from the Vinmec Tissue Bank and cultured under xeno-free, serum-free and antibiotic-free conditions as previously described. To prepare UC-MSCs for therapy, aliquots of Passage 3 (P3) UC-MSCs will be thawed and cultured to P5 to get approximately 500 million cells and dispensed to 10 million UC-MSCs\u002Fml\u002Fvial for cryopreservation. Upon request from the clinical team, aliquots of P5 UC-MSCs will be thawed in a temperature control water bath or incubator on the infusion day. The UC-MSCs will be washed and suspended in Ringer Lactate.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Tan Sinh Nguyen, Dr","Vinmec Times City International Hospitalme","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Phuong Nguyen, MSC","CONTACT","+84 914740683","v.phuongnh9@vinmec.com",{"name":38,"role":34,"phone":25,"phoneExt":25,"email":39},"Liem Nguyen, PhD","v.liemnt@vinmec.com",[41],{"facility":5,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":48,"coordinates":49},"Point",[50,51],105.84117,21.0245,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":56,"phoneExt":25,"email":36},"Nguyen T Liem, Prof","+84914740683",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100465799","phase-1-umbilical-cord-derived-mesenchymal-stem-cell-vcell-1-for-male-patients-with-sexual-deficiency-100465799",false,"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":70,"type":71},158,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","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.",[78],"Sexual Dysfunction Male",[78,80,81],"reproductive hormones","mesenchymal stem Cell","2024-06-03",{"date":84,"type":85},"2024-06-04","ACTUAL",{"date":87,"type":85},"2022-04-01",{"date":89,"type":71},"2025-12-30",{"name":5,"class":6},1]