[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547466":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":77,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":18,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":18,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental","EXPERIMENTAL","The experimental group will be implanted with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT). The implantation of this advanced therapy medication will cover the lateral defect generated by the mobilization of fibromucous flaps during standard surgery (uranostaphylorrhaphy",[13],"Procedure: implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","NO_INTERVENTION","These patients will be included in the control group and will receive the usual treatment for their disease (uranoestafilorrafia), without applying any type of restriction to the area used for the movement of the arms.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).","cleft palate repair surgery, all patients in the study will receive the standard treatment (uranostaphyllorrhaphy), with the only difference that patients assigned to the experimental study group will additionally have BIOCLEFT tissue obtained through tissue engineering grafted onto them. the lateral area of the palatine bone exposed when mobilizing the flaps. For the implant, the BIOCLEFT fabric will be placed in the area of exposed bone, sized to the size of the defect and sutured using uncoated, monofilament long-term absorbable synthetic suture.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Elisa Cubiles","CONTACT","955048278","emontero@fibao.es",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Soraya Santana","618 93 00 77","ssantana@fibao.es",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Hospital Virgen de las Nieves","RECRUITING","Granada","Spain\u002FGranada","18014","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-3.60667,37.18817,{"lat":48,"lon":47},[51,55,60,62,65,67,69,71,73,75],{"name":52,"role":28,"phone":53,"phoneExt":18,"email":54},"Ricardo Fernández, MD,PhD","671 593 192","rfdezvalades@me.com",{"name":56,"role":28,"phone":57,"phoneExt":58,"email":59},"Miguel Alaminos, MD, PhD","958 241000","20461","malaminos@ugr.es",{"name":52,"role":61,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":64,"phone":18,"phoneExt":18,"email":18},"Antonio España, MD,PhD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":18,"phoneExt":18,"email":18},"Esther Liceras, MD, PhD",{"name":68,"role":64,"phone":18,"phoneExt":18,"email":18},"Daniel Vallejo, MD, PhD",{"name":70,"role":64,"phone":18,"phoneExt":18,"email":18},"Adoración Martínez, MD, PhD",{"name":72,"role":64,"phone":18,"phoneExt":18,"email":18},"Ana Marín, MD, PhD",{"name":74,"role":64,"phone":18,"phoneExt":18,"email":18},"Rosario Cortés, MD, PhD",{"name":76,"role":64,"phone":18,"phoneExt":18,"email":18},"Belén Pérez, MD, PhD",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Elisa María Cubiles Montero de Espinosa","responsible for clinical trials",[82],{"name":83,"class":6},"Andalusian Network for Design and Translation of Advanced Therapies","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":95,"type":96},15,"ESTIMATED","INTERVENTIONAL",[99,100],"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.",[103],"Cleft Lip and Palate","2024-05-06",{"date":106,"type":107},"2024-05-10","ACTUAL",{"date":109,"type":107},"2024-04-17",{"date":111,"type":96},"2028-12-17",{"name":79,"class":6},1]