[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637926":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":72,"collaborators":28,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":104,"whyStopped":28,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Young adults","EXPERIMENTAL","Female and male volunteers aged 18-40 years",[13],"Procedure: Skin biopsy and venous blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Middle-aged adults","Female and male volunteers aged 40-60 years",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Elderly adults","Female and male volunteers aged 60-90 years",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Skin biopsy and venous blood sampling","A single 3-4 mm punch biopsy of forearm skin is performed under local anesthesia (lidocaine 1% with epinephrine 1:100,000) for primary dermal fibroblast isolation. Venous blood is collected by standard phlebotomy from the antecubital fossa (43 mL total volume per participant): 5 mL in SST tube for serum separation, 3 mL in EDTA tube for plasma separation, 32 mL in EDTA tubes for PBMC isolation by density gradient centrifugation, and 3 mL in Tempus Blood RNA tube for whole-blood RNA stabilization. All procedures are performed at a single visit at enrollment. Samples are processed for biospecimen-based ex vivo molecular and cellular analyses; no investigational product is administered to participants.",[19,15,9],null,[30],{"name":31,"affiliation":32,"role":33},"Giuseppe Remuzzi","Istituto Di Ricerche Farmacologiche Mario Negri","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Luca Perico, PhD","CONTACT","+3903542131","luca.perico@marionegri.it",{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},"Miriam Rigoldi, MD","+390354535327","miriam.rigoldi@marionegri.it",[45,61],{"facility":46,"status":28,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Laboratory for Targeted Therapy in Autoimmune Diseases","Bergamo","BG","24126","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],9.66721,45.69601,{"lat":56,"lon":55},[59],{"name":36,"role":37,"phone":60,"phoneExt":28,"email":39},"+3003542131",{"facility":62,"status":28,"city":63,"state":48,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Centro di Ricerche Cliniche per le Malattie Rare \"Aldo e Cele Daccò\"","Ranica","24020",{"type":53,"coordinates":66},[67,68],9.71335,45.72328,{"lat":68,"lon":67},[71],{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},{"type":73,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100637926","mitigating-mitochondrial-rna-release-during-aging-to-control-inflammation-and-senescence-100637926",false,"NCT07596615","Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence","Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence, Preserving Organ Function and Enhancing Healthspan","MIRACLE","Inclusion Criteria:\n\n* Male and female\n* Age between 18 and 90 years (stratified in three groups: young, middle-aged, elderly)\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to understand the potential risk and benefits of the study\n* Legal incapacity\n* Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days\n* Diagnosis of diabetes mellitus\n* Use of anticoagulant medications\n* Any subject with a contraindication to the mini-invasive biopsy procedure",true,"ALL","18 Years","90 Years",{"count":87,"type":88},90,"ESTIMATED","INTERVENTIONAL",[91],"NA","The MIRACLE study aims to investigate age-related mitochondrial dysfunction, mitochondrial RNA (mtRNA) release, inflammation, and cellular senescence in adult participants across three age groups. Skin-derived fibroblasts and peripheral blood mononuclear cells (PBMCs) will be isolated from skin biopsy and blood samples to characterize age-related cellular and molecular changes and to test experimental therapeutic strategies identified in preclinical studies. Serum, plasma, and whole-blood RNA will be used for protocol-defined analyses of circulating inflammatory mediators and systemic transcriptional signatures related to inflammation, type I interferon activation, mitochondrial stress response, immune aging, and senescence-associated pathways.",[94,95,96],"Aging","Inflammation","Healthy Ageing",[98,99,100,101,102,103],"mitochondrial dysfunction","skin-derived fibroblasts","mtRNA","PBMCs","senescence","inflammaging","NOT_YET_RECRUITING","2026-05-12",{"date":107,"type":108},"2026-05-19","ACTUAL",{"date":110,"type":88},"2026-09",{"date":112,"type":88},"2031-09",{"name":5,"class":6},2]