[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Elisa María Cubiles Montero de Espinosa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100547466","phase-1-phase-i-iia-to-evaluate-the-safety-feasibility-and-efficacy-of-the-use-of-biocleft-in-the-treatment-of-cleft-palate-100547466",false,"NCT06408337","Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.","Phase I-IIa, Randomized, Controlled, Open-label, Single-center Clinical Trial to Evaluate Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Patients With Cleft Palate","Inclusion Criteria:\n\n* Pediatric patients, of both sexes.\n* Diagnosis of total unilateral non-syndromic cleft lip and palate (FLPNS) that will undergo surgery for correction.\n* Children who have previously donated a sample of oral mucosa during the cleft lip repair procedure (cheiloplasty).\n* Informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions.\n\nExclusion Criteria:\n\n* Active infectious diseases.\n* Allergies or hypersensitivity to any of the components\u002Fexcipients of the Investigational Product.\n* Severe hematological disorders\u002Fblood dyscrasias.\n* Severe hepatic or renal dysfunction\u002Ffailure.\n* Serious endocrine disorders\u002Fdysfunctions.\n* Malignant neoplasms\n* Active HIV, HBV or HCV infection.\n* Metabolic bone diseases (Paget's disease, hypercalcemia, etc.).\n* Children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affect the result of the study or the interpretation of the results of the study.\n* Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.","ALL","10 Months","14 Months",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase I\u002FII, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.",[28],"Cleft Lip and Palate","RECRUITING","2024-05-06",{"date":32,"type":33},"2024-05-10","ACTUAL",{"date":35,"type":33},"2024-04-17",{"date":37,"type":21},"2028-12-17",{"name":39,"class":40},"Elisa María Cubiles Montero de Espinosa","OTHER",""]