[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287618":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":118,"collaborators":20,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":20,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":20,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"BonusBio Group Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Clinical Interventions:\n\n1. Blood tests: complete blood count, full blood chemistry and biochemistry including phosphate, alkaline phosphatase, calcium, renal and liver function, and coagulation. Serology tests: HIV, Hepatitis B, Hepatitis C.\n2. Xray\n3. Urine Test\n4. CT\n5. Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen\n6. Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect\u002Fcritical gap",[13],"Biological: BonoFill-II",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BonoFill-II","Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion.\n\nA standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed.\n\ninternal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nimrod Rozen, MD, PhD","Emek Medical Center, Afula, Israel","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+972-4-649-4201","nimrod_rozen@hotmail.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Vered Kivity, PhD, MBA","+972-73-206-7103","veredki@bonus-bio.com",[36,52,66,80,94,104],{"facility":37,"status":38,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Emek Medical Center","RECRUITING","Afula","1834111","Israel","IL",{"type":44,"coordinates":45},"Point",[46,47],35.2892,32.60907,{"lat":47,"lon":46},[50],{"name":23,"role":28,"phone":51,"phoneExt":20,"email":30},"04-6494201",{"facility":53,"status":38,"city":54,"state":20,"zip":55,"country":41,"countryCode":42,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Barzilai Medical Center","Ashkelon","7830604",{"type":44,"coordinates":57},[58,59],34.57149,31.66926,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":64,"phoneExt":20,"email":65},"Omri Lubovski, MD","972-8-6745034","omril@bmc.gov.il",{"facility":67,"status":38,"city":68,"state":20,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Hillel Yafe","Hadera",{"type":44,"coordinates":70},[71,72],34.9039,32.44192,{"lat":72,"lon":71},[75,79],{"name":76,"role":28,"phone":77,"phoneExt":20,"email":78},"Yaniv Yonay, MD","972-4-7744738","yanivy@hy.health.gov.il",{"name":76,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":81,"status":38,"city":82,"state":20,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Carmel Medical Center","Haifa",{"type":44,"coordinates":84},[85,86],34.99928,32.81303,{"lat":86,"lon":85},[89,93],{"name":90,"role":28,"phone":91,"phoneExt":20,"email":92},"Benny Bernfeld, MD","972-4-8250506","bernfeld_benny@clalit.org.il",{"name":90,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":95,"status":38,"city":82,"state":20,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Rambam Health Campus",{"type":44,"coordinates":97},[85,86],{"lat":86,"lon":85},[100,103],{"name":101,"role":28,"phone":20,"phoneExt":20,"email":102},"Doron Norman, MD, PhD","d_norman@rmc.gov.il",{"name":101,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":105,"status":38,"city":106,"state":20,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Meir Medical Center","Kfar Saba",{"type":44,"coordinates":108},[109,110],34.90694,32.175,{"lat":110,"lon":109},[113,117],{"name":114,"role":28,"phone":115,"phoneExt":20,"email":116},"Nissim Ohana, MD","972-9-7472502","ohanan@clalit.org.il",{"name":114,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":119,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100287618","phase-1-enhancement-of-bone-regeneration-and-healing-in-the-extremities-by-the-use-of-autologous-bonofill-ii-100287618",false,"NCT03024008","Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II","A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II","Inclusion Criteria:\n\n* Long and short bones extra articular comminuted fracture or\n* Long and short bones extra and intra articular defect\u002Fgap or non union, incapable of self-regeneration\n\nExclusion Criteria:\n\n* Age is under 18 or above 80\n* A simple fracture manageable by one definitive treatment\n* Pregnant or lactating women\n* Patients with active infection that is in question and needs osteogenic treatment.\n* More than 3 previous failed interventions at the surgical site\n* History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \\\u003C30 ml\u002Fmin\u002F1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C)\n* Diabetic subjects (HbA1c \\> 8)\n* Subject treated currently with systemic steroids.\n* Subjects with known autoimmune diseases, such as Addison's disease, Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus.\n* Subjects diagnosed with osteoporosis\n* Chronic severe PVD (Peripheral Vascular Disease) subjects\n* Post major vascular operation in the treated limb\u002Fs and above the surgical site (with or without Gore-Tex grafting)\n* Subjects that have a known scar healing problem (keloid formation).\n* Subjects treated with Bisphosphonate drugs\n* Oncology patient or subjects who received chemotherapy or radiotherapy treatment in the past 12 months\n* Immunocompromised condition from any reason, at screening\n* Subjects participating in another clinical trial 30 days prior to and during the study period.\n* Drug addicts and psychiatric patients patients incapable of giving consent.\n* Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation\n* Subjects with any known allergy for local\u002Fgeneral anesthesia\n* Positive serology for either HIV, hepatitis B or hepatitis C\n* Abnormal clinically significant laboratory test and findings, as per the investigator's judgment","ALL","18 Years","80 Years",{"count":131,"type":132},40,"ESTIMATED","INTERVENTIONAL",[135,136],"PHASE1","PHASE2","The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:\n\n1. Long and short bone extra-articular comminuted fracture\n2. Long and short bones extra and intra articular defect \u002FGap or non-union, incapable of self-regeneration",[139],"Bone Fracture",[141,142,143],"Critical Gap","Comminuted Fracture","Extra-Articular","2025-12-03",{"date":146,"type":147},"2025-12-10","ACTUAL",{"date":149,"type":147},"2017-07-27",{"date":151,"type":132},"2027-06",{"name":5,"class":6},6]