[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396899":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":39,"centralContacts":44,"locations":51,"responsibleParty":71,"collaborators":49,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":38,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":49,"enrollmentInfo":82,"targetDuration":49,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":95,"whyStopped":49,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Celltex Therapeutics Corporation","INDUSTRY",[8,14,19,22,25,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2 Arm 1 - OA Knee","EXPERIMENTAL","50 subjects receive two doses of 2.0-2.86 x 10\\^6 cells\u002Fkg on days 0 and 6 via intravenous infusion.\n\nOn day 3, each subject will receive a single dose of 1.0-2.86 x 10\\^6 cells\u002Fkg via intra-articular injection into the injured joint.",[13],"Biological: Celltex- AdMSCs",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase 2 Arm 2 OA Knee","ACTIVE_COMPARATOR","Control group- 50 subjects receive three doses of 2.0-2.86 x 10\\^6 cells\u002Fkg on day 0, 3, and 6 via intravenous infusion",[13],{"label":20,"type":10,"description":11,"interventionNames":21},"Phase 2 Arm 3 - OA Hip",[13],{"label":23,"type":16,"description":17,"interventionNames":24},"Phase 2 Arm 4 - OA Hip",[13],{"label":26,"type":10,"description":11,"interventionNames":27},"Phase 2 Arm 5 - OA Shoulder",[13],{"label":29,"type":16,"description":17,"interventionNames":30},"Phase 2 Arm 6 - OA Shoulder",[13],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Celltex- AdMSCs","Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue",[9,15,20,23,26,29],[38],"AdMSCs",[40],{"name":41,"affiliation":42,"role":43},"Derek W Guillory, MD.","Root Causes Medicine","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Jane Young","CONTACT","7135901000",null,"jyoung@celltexbank.com",[52],{"facility":53,"status":49,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Stanley C Jones","Houston","Texas","77098","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-95.36327,29.76328,{"lat":63,"lon":62},[66],{"name":67,"role":47,"phone":68,"phoneExt":69,"email":70},"Sally McGahee, BS","713-590-1000","147","smcgahee@celltexbank.com",{"type":72,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100396899","phase-2-autologous-adipose-tissue-derived-mesenchymal-stem-cells-admscs-for-osteoarthritis-100396899",false,"NCT04448106","Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis","Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)","Inclusion Criteria:\n\n* Age above 18 years\n* Male or female\n* Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)\n* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures\n* Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.\n\nExclusion Criteria:\n\n* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start\n* Unwillingness or inability to comply with study procedures\n* Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.\n* Clinically active malignant disease\n* Previous thrombotic disorder\n* History of known pulmonary embolism or known secondary anti-phospholipid syndrome\n* Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)\n* Major trauma or surgery within 14 days of study treatment start\n* Mental condition rendering the subject (or the subject's legally acceptable representative\\[s\\]) unable to understand the nature, scope and possible consequences of the study\n* Alcohol, drug, or medication abuse within one year prior to study treatment start\n* Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study\n* Irreversible severe end-organ failure, such as heart failure\u002Fattack, stroke, liver and renal failure due to other disease conditions\n* Patients or family history with a hypercoagulable status, such as protein C\u002Fprotein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.\n* History of long-term use of immunosuppressive agents\n* Organ transplants in the previous 6 months\n* Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study","ALL","18 Years",{"count":83,"type":84},300,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).",[90,91,92],"Osteoarthritis, Knee","Osteoarthritis, Hip","Osteoarthritis Shoulder",[94],"Autologous Adipose-derived Stem Cells (AdMSCs)","NOT_YET_RECRUITING","2023-04-13",{"date":98,"type":99},"2023-04-18","ACTUAL",{"date":101,"type":84},"2023-09-25",{"date":103,"type":84},"2026-08-15",{"name":5,"class":6},1]