[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04448106":3,"trial-entities:NCT04448106":129,"trial-summary:NCT04448106":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":53,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":97,"locations":100,"central_contacts":117,"overall_officials":122,"references":127,"see_also_links":128},"NCT04448106","CTX0020-002","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)","UNKNOWN","2026-08-15","2023-04","2023-04-18","2023-09-25","Celltex Therapeutics Corporation","INDUSTRY",false,"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).",null,[19,20,21],"Osteoarthritis, Knee","Osteoarthritis, Hip","Osteoarthritis Shoulder",[23],"Autologous Adipose-derived Stem Cells (AdMSCs)","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},300,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":43},"BIOLOGICAL","Celltex- AdMSCs","Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue",[37,38,39,40,41,42],"Phase 2 Arm 1 - OA Knee","Phase 2 Arm 2 OA Knee","Phase 2 Arm 3 - OA Hip","Phase 2 Arm 4 - OA Hip","Phase 2 Arm 5 - OA Shoulder","Phase 2 Arm 6 - OA Shoulder",[44],"AdMSCs",[46,50],{"measure":47,"description":48,"timeFrame":49},"the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.","safety","12 months",{"measure":51,"description":52,"timeFrame":49},"Any organ damage or safety concerns determined by SMAC 20 blood test.","Safety",[54,57,59,61,63,66,68],{"measure":55,"description":56,"timeFrame":49},"Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients","efficacy",{"measure":58,"description":56,"timeFrame":49},"Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients",{"measure":60,"description":56,"timeFrame":49},"Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients",{"measure":62,"description":56,"timeFrame":49},"Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients",{"measure":64,"description":56,"timeFrame":65},"Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients","12 month",{"measure":67,"description":56,"timeFrame":49},"Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients",{"measure":69,"description":56,"timeFrame":49},"changes in joint images (X-ray or MRI) from the baseline","ALL","18 Years",{"inclusion":73,"exclusion":79,"raw_text":96},[74,75,76,77,78],"Age above 18 years","Male or female","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)","Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures","Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95],"Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start","Unwillingness or inability to comply with study procedures","Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.","Clinically active malignant disease","Previous thrombotic disorder","History of known pulmonary embolism or known secondary anti-phospholipid syndrome","Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)","Major trauma or surgery within 14 days of study treatment start","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","Alcohol, drug, or medication abuse within one year prior to study treatment start","Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study","Irreversible severe end-organ failure, such as heart failure\u002Fattack, stroke, liver and renal failure due to other disease conditions","Patients or family history with a hypercoagulable status, such as protein C\u002Fprotein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.","History of long-term use of immunosuppressive agents","Organ transplants in the previous 6 months","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","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",[98,99],"ADULT","OLDER_ADULT",[101],{"facility":102,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":114},"Stanley C Jones","Houston","Texas","77098","United States",[108],{"name":109,"role":110,"phone":111,"phoneExt":112,"email":113},"Sally McGahee, BS","CONTACT","713-590-1000","147","smcgahee@celltexbank.com",{"lat":115,"lon":116},29.76328,-95.36327,[118],{"name":119,"role":110,"phone":120,"email":121},"Jane Young","7135901000","jyoung@celltexbank.com",[123],{"name":124,"affiliation":125,"role":126},"Derek W Guillory, MD.","Root Causes Medicine","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":130,"biomarkers":132},[131],"Osteoarthritis",[],{"nct_id":4,"found":134,"summary":135,"prompt_version":144},true,{"design":136,"status":137,"heading":6,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is a Phase 2, open-label study with 6 groups, including a study group and a control group for each joint type. It will involve 300 participants with osteoarthritis of the knees, hips, or shoulders.","completed","This study is investigating a treatment called Celltex-AdMSCs for osteoarthritis in the knees, hips, and shoulders. Celltex-AdMSCs are mesenchymal stem cells taken from your own abdominal fat tissue. The study aims to see how safe this treatment is by tracking any side effects over 12 months and checking for organ damage with a blood test. You can join if you are over 18 years old and have osteoarthritis. You must also have previously banked your AdMSCs at Celltex and passed certain health screenings. The study plans to enroll 300 participants, but its current status is unclear.","Participants will be followed for 12 months to monitor for adverse events and safety concerns.",96,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]