[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572846":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":113,"collaborators":26,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":26,"enrollmentInfo":125,"targetDuration":26,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"single dose of 40 million HC016","EXPERIMENTAL","They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells\u002FmL. N=40",[13],"Drug: allogeneic mesenchymal stem cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline solution","PLACEBO_COMPARATOR","They will receive a single dose of the saline solution in which the HC016 cells are conditioned, which consists of lactated ringer's, glucosaline, sodium bicarbonate and human albumin. N=20",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","allogeneic mesenchymal stem cells","Cell implantation is carried out in the following steps:\n\n1. \\- Patient anesthesia\n2. \\- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy.\n3. \\- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately.\n4. \\- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \\\u003C22G) at 2 points of the sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically.\n5. \\- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo implantation is carried out in the same way as the drug implantation",[15],[32],{"name":33,"affiliation":5,"role":34},"Carmen González Enguita, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+34915504957","cgenguita@fjd.es",{"name":41,"role":37,"phone":42,"phoneExt":43,"email":44},"Mariano García Arranz, PhD","+34915504800","3398","mariano.garcia@quironsalud.es",[46,63,75,84,96,106],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hospital Universitario del Henares","RECRUITING","Coslada","Madrid","28822","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],-3.56129,40.42378,{"lat":58,"lon":57},[61],{"name":62,"role":37,"phone":26,"phoneExt":26,"email":26},"Manuel Fernández Arjona, PhD",{"facility":64,"status":48,"city":50,"state":50,"zip":65,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Fundación Jiménez Díaz","28040",{"type":55,"coordinates":67},[68,69],-3.70256,40.4165,{"lat":69,"lon":68},[72,73],{"name":41,"role":37,"phone":42,"phoneExt":26,"email":44},{"name":74,"role":34,"phone":26,"phoneExt":26,"email":26},"Carmen Énguita, PhD",{"facility":76,"status":48,"city":50,"state":50,"zip":77,"country":52,"countryCode":53,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Hospital Universitario Doce de Octubre","28041",{"type":55,"coordinates":79},[68,69],{"lat":69,"lon":68},[82],{"name":83,"role":37,"phone":26,"phoneExt":26,"email":26},"Jose Medina Polo, PhD",{"facility":85,"status":48,"city":86,"state":50,"zip":87,"country":52,"countryCode":53,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Universitario Rey Juan Carlos","Móstoles","28933",{"type":55,"coordinates":89},[90,91],-3.86496,40.32234,{"lat":91,"lon":90},[94],{"name":95,"role":37,"phone":26,"phoneExt":26,"email":26},"Miguel Sánchez Encinas, PhD",{"facility":97,"status":98,"city":99,"state":50,"zip":100,"country":52,"countryCode":53,"cosmosGeoPoint":101,"geoPoint":105,"contacts":26},"Hospital Universitario Infanta Elena","ACTIVE_NOT_RECRUITING","Valdemoro","28342",{"type":55,"coordinates":102},[103,104],-3.67887,40.19081,{"lat":104,"lon":103},{"facility":107,"status":48,"city":108,"state":50,"zip":109,"country":52,"countryCode":53,"cosmosGeoPoint":26,"geoPoint":26,"contacts":110},"Hospital Universitario General de Villalba.","Villalba","28400",[111],{"name":112,"role":37,"phone":26,"phoneExt":26,"email":26},"Santiago Alonso Bartolomé, PhD",{"type":114,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100572846","phase-1-allogeneic-use-of-expanded-mesenchymal-stem-cells-derived-from-adipose-tissue-hc106-female-urinary-incontinence-women-over-50-years-old-100572846",false,"NCT06738576","Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old","Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age","SUITH)","Inclusion Criteria:\n\n* Women over 50 years old\n* Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate.\n\nThe predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.\n\n* Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment\n* Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment\n* Signing of the informed consent form\n\nExclusion Criteria:\n\n* Patients with a medical history of previous surgery for incontinence, prolapse or urological\u002Fgynecological\u002Fcolorectal surgery\n* Major surgery or serious trauma of the subject in the previous semester\n* Women with mixed urinary incontinence, with predominant symptoms of urgency\n* History of high-pressure detrusor overactivity\n* Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by urethrocystoscopy, urethrocystography and flowmetry).\n* Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years.\n* Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious enough to exclude the patient from the study.\n* Medical or psychiatric illness of any type that, in the opinion of the researcher, may be a reason for exclusion from the study.\n* History of alcohol or other addictive substance abuse in the 6 months prior to inclusion\n* Subject's allergy to anesthetics","FEMALE","50 Years",{"count":126,"type":127},60,"ESTIMATED","INTERVENTIONAL",[130],"PHASE1","Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.",[133],"Urinary Incontinence Stress","2025-04-29",{"date":136,"type":137},"2025-05-01","ACTUAL",{"date":139,"type":137},"2024-12-16",{"date":141,"type":127},"2025-12",{"name":5,"class":6},6]