[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"induced-pluripotent-stem-cells-ipsc-production\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:induced-pluripotent-stem-cells-ipsc-production":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100649557","safe-ips---frances-first-hospital-based-platform-for-the-production-of-induced-pluripotent-stem-cells-for-the-regenerative-medicine-of-the-future-100649557",false,"NCT07735559","SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future","SAFE-iPS","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 35 years\n* No medical contraindication to a 54 mL blood sample collection\n* Negative viral serology for:\n\n  * Human Immunodeficiency Virus (HIV)\n  * Hepatitis B Virus (HBV)\n  * Hepatitis C Virus (HCV)\n  * Human T-lymphotropic Virus type 1 (HTLV-1)\n* A participant who agrees to have their anonymized biological samples and cell lines stored in a biological sample collection for other research purposes (including genetic research)\n\nExclusion Criteria:\n\n* Any active medical condition\n* Any ongoingl treatment\n* Subjects who cannot read and\u002For write\n* Inability to ensure participant during the study period\n* Participation in another clinical trial or administration of an off-label medication that could interfere with blood test results.\n* Participation in another research protocol involving biological sampling that limits the number of mL to be collected.\n* Failure to obtain informed consent\n* Not enrolled in a social security program,\n* Subject participating in another research study with an ongoing exclusion period\n* Protected populations under the French Public Health Code (women who are giving birth, breastfeeding, or pregnant; subjects deprived of liberty by judicial or administrative decision; adults under legal protection (under any form of guardianship))",true,"ALL","18 Years","35 Years",{"count":21,"type":22},6,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of the study is to establish the first French hospital-based Good Manufacturing Practice (GMP)-compliant platform for the production of clinical-grade induced pluripotent stem cells (iPSCs) for future regenerative medicine applications.\n\nThe primary objective is to generate, via the SAFE-iPS platform, 4 clinical-grade iPSC lines derived from peripheral blood samples taken from:\n\n* Two healthy male volunteers\n* Two healthy female volunteers\n\nThese 4 iPSC lines will undergo comprehensive quality assessment including:\n\n* Expression of pluripotency markers\n* Genomic stability assessment\n* Absence of residual Sendai viral integration\n* Technical reproducibility assessment\n* Manufacturing efficiency assessment\n* Preliminary medico-economic evaluation This project aims to demonstrate that the SAFE-iPS manufacturing process can be successfully transferred to a hospital Good Manufacturing Practice (GMP) environment and can reproducibly generate clinical-grade iPSC lines meeting international quality standards for future regenerative medicine applications. It also aims to establish the first French public hospital platform dedicated to routine GMP production of clinical-grade iPSCs.",[28,29],"Regenerative Medicine","Induced Pluripotent Stem Cells (iPSC) Production",[31,32,33,34,35],"Induced pluripotent stem cells (iPSCs),","regenerative medicine,","cell therapy","directed differentiation","clinical-grade production (or GMP manufacturing)","NOT_YET_RECRUITING","2026-07-27",{"date":39,"type":40},"2026-07-30","ACTUAL",{"date":42,"type":22},"2026-11",{"date":44,"type":22},"2028-02",{"name":46,"class":47},"University Hospital, Montpellier","OTHER"]