[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celltex Therapeutics Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100440592","phase-2-clinical-study-for-subjects-with-covid-19-using-allogeneic-adipose-tissue-derived-mesenchymal-stem-cells-100440592",false,"NCT05017298","Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells","Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)","AdMSCs","Inclusion Criteria:\n\n* Age above 18 years.\n* Male and female\n* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures\n* Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive\n* Clinical diagnosis meets severe and\u002For critical parameters\n* Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity\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* Subjects who are receiving ECMO and CRRT currently\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* Known or suspected allergic to diphenhydramine.\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 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 past 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.\n* Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.\n* QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.\n* Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.",[27,28],"Corona Virus Infection","Covid19","NOT_YET_RECRUITING","2024-02-05",{"date":32,"type":33},"2024-02-07","ACTUAL",{"date":35,"type":21},"2024-11-01",{"date":37,"type":21},"2026-11-15",{"name":39,"class":40},"Celltex Therapeutics Corporation","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":15,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100396899","phase-2-autologous-adipose-tissue-derived-mesenchymal-stem-cells-admscs-for-osteoarthritis-100396899","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",{"count":49,"type":21},300,[24],"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).",[53,54,55],"Osteoarthritis, Knee","Osteoarthritis, Hip","Osteoarthritis Shoulder",[57],"Autologous Adipose-derived Stem Cells (AdMSCs)","2023-04-13",{"date":60,"type":33},"2023-04-18",{"date":62,"type":21},"2023-09-25",{"date":64,"type":21},"2026-08-15",{"name":39,"class":40},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100395415","phase-2-autologous-adipose-derived-stem-cells-admscs-for-covid-19-100395415","NCT04428801","Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19","Clinical Study for the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19)","Inclusion Criteria:\n\n* Age above 18 years.\n* Male or female\n* Subjects should have banked AdMSCs in Celltex (already passed communicable disease screen tests for HIV, syphilis, 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* Highly susceptible to SARS-Cov-2 infections, such as obesity (BMI ≥ 40), early to middle stage of hypertension (systolic pressure ranging above 140 Hg or a diastolic pressure ranging from 90 mm Hg), diabetic mellitus hemoglobin A1c \\>8%), chronic heart disease (one or more conditions including previously diagnosed as coronary artery disease, chronic heart arrhythmia, cardiomyopathy…) chronic pulmonary disease (COPD, fibrosis), chronic liver disease (Hepatic impairment, defined as any of ALT, AST, LDH or bilirubin \\> 2 x the upper limit of normal (ULN) range according to local laboratory standards) and kidney diseases (serum creatinine \\> 133 mmol\u002FL (1.5 mg\u002FdL). No terminal stages of the above medical conditions.\n* No previous COVID-19 history\n* SARS-CoV-2 RT-PCR or equivalent tests negative in respiratory tract specimen\n* Blood test for SARS-Cov-2 IgM and IgG negative\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* Blood test for SARS-Cov-2 antibodies IgM and IgG positive\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 in the Investigator's opinion that is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study\n* Irreversible severe end-organ failures, such as heart failure\u002Fattack, stroke, liver and renal failure due to other disease conditions\n* Patients or family history with hypercoagulable states, 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 transplant in the past 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\n* Patients with severe pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia. This includes patients with pulmonary imaging that reveals interstitial lung damage before contracting COVID-19.\n* QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.",{"count":75,"type":21},200,[24],"This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events\u002Fsevere adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL\\_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.",[79],"COVID-19",[81],"Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19 [NCT ID not yet assigned]",{"date":60,"type":33},{"date":84,"type":21},"2023-09",{"date":86,"type":21},"2026-09",{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100375586","phase-1-autologous-adipose-derived-stem-cells-admscs-for-rheumatoid-arthritis-100375586","NCT04170426","Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis","Phase 1\u002F2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)","Inclusion Criteria:\n\n* Must pass communicable disease screen tests for HIV, syphilis, Hepatitis B and C Consistent with American Rheumatism Association-European League Against Rheumatism (ACR\u002FEULAR) 2010 rheumatoid arthritis classification criteria\n* Active Rheumatoid Arthritis, see RA functional status of class I-IV\n* Patients must meet at least one of the following: \\> 6 swollen joints and ≥ 6 involved joints (tenderness, swelling, deformity, pain on motion, or decreased motion) and morning stiffness ≥ 45 minutes based on 68 joint count.\n* Patients must also meet at least one of the following: rheumatoid factor (RF) \\> 15 IU\u002FmL or \\> 1:16, C-reactive protein (CRP) \\> 2.0 mg\u002FdL, Erythrocyte Sedimentation Rate (ESR) \\> 30 mm\u002Fhour, and anti-cyclic citrullinated protein (Anti-CCP) \\> 20 U\u002FmL, TNFα \\> 2.8 pg\u002FmL.\n* Patients must have failed anti-rheumatoid drug due to adverse event or inefficacy for at least 12 week and at least 4 weeks on stable dose of methotrexate ≤ 25 mg\u002Fweek, or leflunomide ≤ 20 mg\u002Fday, or sulfasalazine ≤ 3 g\u002Fday, or steroids (Prednisone \\\u003C10 mg\u002Fday).\n* For other medications, patients must be on the stable dose for at least 4 weeks prior to study entry in order to preclude changes to patient medication while participating on the study to ensure that a medication change could become a confounding factor in data interpretation.\n* All patients must be clinically stable with no significant changes in health status a minimum of at least 4 weeks prior to randomization and confirming patient eligibility\n\nExclusion Criteria:\n\n1. Current or prior to treatment\n\n   * Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start\n   * Evidence of immune suppression related to prior\u002Fcurrent therapy\n   * \\> 10% change in delivered monthly dose of anti-rheumatoid medications within 4 weeks prior to this stem cell infusion\n   * Use of a new or additional anti-rheumatoid medication within 6 weeks prior to this stem cell infusion\n   * Use of other stem cell therapy within 12 weeks prior to this stem cell therapy\n   * Unwillingness or inability to comply with study procedures\n2. Concurrent Conditions\n\n   * Clinically active malignant disease\n   * Severe bladder or 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 or store the AdMSCs, e.g. sulfur or sulfonamide\n   * Known or suspected antibodies to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)\n   * Active infection at time of planned study treatment start\n   * Age related pathology likely to inhibit study participation or completion\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 before 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\n   * Heavy smokers, bed-bound patients, patients or family history with hypercoagulable status, such as protein C\u002Fprotein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.\n3. Laboratory Parameters\n\n   * Hepatic impairment, defined as any of ALT, AST, LDH or bilirubin \\> 2 x the upper limit of normal (ULN) range according to local laboratory standards\n   * Renal impairment, defined as serum creatinine \\> 133 mmol\u002FL (1.5 mg\u002FdL)\n   * Positive virology\u002Fserology for human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), hepatitis C and\u002For syphilis\n4. Pregnancy \u002F contraception\n\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","75 Years",{"count":97,"type":21},54,[99,24],"PHASE1","This is an investigational new drug clinical trial for combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using intravenous injection of autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients. All subjects are monitored for safety (adverse events\u002Fsevere adverse events) and evaluated for RAPID3, DAS28 and ACR20 regarding AdMSCs up to 52 weeks study duration.",[102],"Rheumatoid Arthritis",{"date":60,"type":33},{"date":105,"type":21},"2023-12",{"date":107,"type":21},"2026-12",{"name":39,"class":40},""]