[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580788":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":36,"studyType":110,"phases":111,"briefSummary":114,"conditions":115,"keywords":36,"overallStatus":70,"whyStopped":36,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"CellARTs Inc.","INDUSTRY",[8,17,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Fertile Males","ACTIVE_COMPARATOR","Fertile male participants (control group) with no known infertility conditions undergoing a vasectomy reversal. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).",[13,14,15,16],"Genetic: Stem cell","Genetic: Genetic Screening","Genetic: Genetic Reprogramming","Genetic: Cell Maturation",{"label":18,"type":19,"description":20,"interventionNames":21},"Infertile Males with Genetic Sterility: Sertoli Cell Only","EXPERIMENTAL","Sterile male participants with unexplained or defined genetic infertility of sertoli cell only that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).",[13,14,15,16],{"label":23,"type":19,"description":24,"interventionNames":25},"Infertile Males with Genetic Sterility: Early\u002FLate Maturation Arrest","Sterile male participants with unexplained or defined genetic infertility of early to late maturation arrest that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participant will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).",[13,14,15,16],{"label":27,"type":19,"description":28,"interventionNames":29},"Infertile Men with Acquired Sterility","Sterile male participants with acquired infertility from chemotherapy, infection, undecended testicles that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).",[13,14,15,16],[31,37,44,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"GENETIC","Stem cell","Primary cell cultures of tissue cells will be established. Cell cultures will undergo genetic reprogramming to induce the long-term propagation of living cells.",[9,23,18,27],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Genetic Screening","Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.",[9,23,18,27],[42,43],"genome mapping","genome characterization",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":36},"Genetic Reprogramming","Genes or gene products will be reinserted into cells to observe how the cells can be changed, or reprogrammed, into embryonic-like cells or into sperm precursor cells.",[9,23,18,27],{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":36},"Cell Maturation","Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.",[9,23,18,27],[53],{"name":54,"affiliation":55,"role":56},"Paul J Turek, MD","Chief Medical Officer","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":36,"email":62},"Erica S Godart, BS","CONTACT","4244579202","ericagodart@gmail.com",{"name":64,"role":60,"phone":65,"phoneExt":36,"email":66},"Constance John, PhD","4153054888","connie.john@gmail.com",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"The Turek Clinic","RECRUITING","San Francisco","California","94108","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-122.41942,37.77493,{"lat":80,"lon":79},[83,86,88],{"name":54,"role":60,"phone":84,"phoneExt":36,"email":85},"4153923200","drpaulturek@gmail.com",{"name":87,"role":60,"phone":84,"phoneExt":36,"email":36},"Lauren Massey, BSN",{"name":54,"role":56,"phone":36,"phoneExt":36,"email":36},{"type":90,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[92],{"name":93,"class":94},"The Turek Clinic, Inc","UNKNOWN","100580788","phase-1-spermatogonial-differentiation-via-testicular-organoid-100580788",false,"NCT06841861","Spermatogonial Differentiation Via Testicular Organoid","A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid","SDTO","Inclusion Criteria: Group 1 (Fertile Control)\n\n* Male sex of reproductive age (between 18 - 60 years old).\n* Evidence of fertility or normal spermatogenesis.\n* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.\n\nInclusion Criteria: Group 2 and 3 (Infertile)\n\n* Male sex of reproductive age (between 18 - 60 years old).\n* Males with evidence of \\>1 year of infertility.\n* Posesses diagnosis of azoospermia is on clinical evaluation.\n* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.\n\nExclusion Criteria:\n\n\\- The lack of diagnosis of fertility or infertility, and lack of testicles.",true,"MALE","18 Years","60 Years",{"count":108,"type":109},100,"ESTIMATED","INTERVENTIONAL",[112,113],"PHASE1","PHASE2","Purpose:\n\nThis clinical trial aims to explore the potential for human sperm production in vitro by sustaining a laboratory-cultured adult testicular environment. It also seeks to identify genetic factors contributing to human sterility and failed spermatogenesis. The study's primary objectives include:\n\n1. Identifying genomic markers associated with sterility and failed spermatogenesis.\n2. Developing an ex vivo (outside the body) testis \"organ-on-a-chip\" (\"iTestis\") to support stem cell cultivation.\n3. Determining whether human spermatogenesis can be re-created in vitro using stem cells nurtured in the iTestis model.\n\nStudy Description:\n\nResearchers will analyze the genomic profiles of fertile and sterile male participants to map genetic abnormalities associated with sterility. Using testicular and skin tissue samples from participants, spermatogonial stem cells and pluripotent stem cells will be isolated and utilized to construct the ex vivo iTestis. This system will integrate genomic insights and prior research to foster human spermatogenesis outside the body.\n\nParticipant Involvement:\n\nParticipants will provide the following samples:\n\n* Blood sample for serum analysis.\n* A skin tissue biopsy.\n* Testicular tissue, obtained through fine needle aspiration (FNA) or testicular sperm extraction (TESE), as part of a routine procedure.\n\nAll procedures will be conducted by the principal investigator and qualified research staff, ensuring participant safety and adherence to ethical guidelines.",[116,117,118],"Infertility, Male","Gene Abnormality","Sterility, Male","2025-02-20",{"date":121,"type":122},"2025-02-24","ACTUAL",{"date":124,"type":122},"2024-03-28",{"date":126,"type":109},"2027-01-01",{"name":5,"class":6},1]