[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Creative Medical Technology Holdings Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,91,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100636173","project-phoenix-molecular-signatures-of-burn-pit-exposure-100636173",false,"NCT07562243","Project PHOENIX: Molecular Signatures of Burn Pit Exposure","Molecular, Genomic, Cellular, and Functional Characterization of Blood Specimens From Former U.S. Service Members With Prior Burn Pit Exposure","PHOENIX","Inclusion Criteria:\n\n* Age 18 years or older at the time of consent\n* Former or current U.S. Service Member, including Active Duty, Reserve, National Guard, or Veteran status\n* For exposed cohort: prior deployment to a location with known burn pit operations, based on participant report and available confirmation when feasible\n* For control cohort: no known deployment to burn pit locations\n* Able and willing to provide informed consent and HIPAA authorization\n* Willing to complete study questionnaires and donate venous blood sample\n* Able to complete study procedures in English or with approved translation support\n* Available for one baseline visit and optional future re-contact, if applicable\n\nExclusion Criteria:\n\n* Active serious illness or infection that, in the investigator's judgment, would compromise participation or specimen integrity\n* Receipt of systemic chemotherapy, immunotherapy, or radiation therapy within the past 6 months\n* High-dose systemic immunosuppression, defined as more than 20 mg prednisone equivalent daily for more than 14 days within the past 3 months\n* Pregnant or currently breast-feeding\n* Hemoglobin less than 10 g\u002FdL, known bleeding disorder, or platelet count less than 100 × 10\\^9\u002FL, if known\n* Severe psychiatric illness or other condition that impairs ability to provide informed consent\n* Prisoner or institutionalized individual\n* Prior participation in this or a related Project PHOENIX protocol\n* Any other condition that, in the investigator's judgment, may increase risk or interfere with study conduct or data integrity",true,"ALL","18 Years",{"count":21,"type":22},1000,"ESTIMATED","5 Years","OBSERVATIONAL","Project PHOENIX is an observational clinical research study designed to characterize molecular, genomic, cellular, and functional features in blood specimens from former U.S. Service Members with prior burn pit exposure and from matched unexposed controls. Participants will complete screening, informed consent, health and exposure questionnaires, and a one-time blood collection. Blood-derived specimens may undergo genomic, epigenomic, transcriptomic, proteomic, metabolomic, immunophenotyping, and cellular functional analyses. Participants may also agree to optional future re-contact for health updates and possible repeat blood collection. The goal is to identify biologic signatures associated with prior deployment-related burn pit exposure and to support future biomarker discovery and translational research in veteran health.",[27,28,29,30,31,32,33],"Burn Pit Exposure","Airborne Hazard Exposure","Veteran Health","Deployment-Related Toxic Exposure","Biomarkers","Immune Dysfunction","Respiratory Symptoms",[35,36,37,38,39,40,41,42,43,44,45,46,47],"Burn pit","Airborne hazards","Veterans","Deployment exposure","Multi-omics","PBMC","Biomarker discovery","Transcriptomics","Epigenomics","Proteomics","Metabolomics","Toxic exposure","Military service","NOT_YET_RECRUITING","2026-04-27",{"date":51,"type":52},"2026-05-01","ACTUAL",{"date":51,"type":22},{"date":55,"type":22},"2031-12-31",{"name":57,"class":58},"Creative Medical Technology Holdings Inc","INDUSTRY",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100487409","phase-1-safety-and-efficacy-of-celz-201-in-patients-with-recent-onset-type-1-diabetes-100487409","NCT05626712","Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes","Clinical Trial to Evaluate the Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (CREATE-1)","CREATE-1","Inclusion Criteria:\n\n1. Subject must be able to understand and provide signed informed consent.\n2. Males and females, 18-35 years of age.\n3. Diagnosis of T1D within 1 year, with stimulated C-peptide peak level \\>0.6 ng\u002FmL as assessed by 4-hour MMTT at the time of Visit 0 (screening).\n4. Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity to at least two islet autoantibodies, GAD65, IA-2, or ZnT8.\n5. Mentally stable and able to comply with the procedures of the study protocol\n6. Subjects must be willing to comply with \"standard-of-care\" diabetes management.\n7. Subjects with eGFR \\>80 ml\u002Fmin\u002F1.73m2\n8. Female subjects of childbearing potential must have a negative pregnancy test upon study entry.\n9. Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study.\n\n   Potential subjects of childbearing potential should agree to use effective contraception for the entire 2-year period.\n10. Adequate venous access to support study required blood draws.\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a subject to give written informed consent or comply with study protocol.\n2. BMI\\>28 kg\u002Fm.\n3. HbA1c \\> 9%\n4. Subjects with poorly controlled hypertension as defined by systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg.\n5. Subjects with any history of cardiac disease, including but not limited to myocardial infarction, uncompensated heart failure, fluid overload, as well as any clinically significant abnormality identified on prior cardiac stress test, angiogram evaluation, or echocardiogram.\n6. Subjects with liver disease, portal hypertension, any coagulopathy (including history of Factor V deficiency) or long-term anti-coagulant therapy (except low-dose aspirin). Other hepatic conditions including hepatic anatomic abnormalities or variants that would place the individual at increased risk in the judgment of the investigator are also considered exclusionary.\n7. Symptomatic cholecystolithiasis; acute or chronic pancreatitis; or current symptomatic peptic ulcer disease.\n8. Subjects with uncontrolled thyroid disease: thyroid stimulating hormone \\\u003C0.3 mU\u002FL or \\>5 mU\u002FL; free T4 \\\u003C5.0 ug\u002FdL or \\>11.0 ug\u002FdL.\n9. Any of the following laboratory findings: hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.2 g\u002FdL (males); leukocytes \\\u003C3,000\u002FμL; neutrophils \\\u003C1,500\u002FμL; lymphocytes \\\u003C800\u002FμL; platelets \\\u003C100,000\u002FμL; elevation in AST and ALT \\>2 x ULN (upper limit of normal); LDL cholesterol \\>160; Triglycerides \\>3 x ULN; total bilirubin \\>1.5 x ULN.\n10. Screening laboratory evidence consistent with significant chronic active infection (i.e.., hepatitis B and C, tuberculosis, and HIV), and IGRA Tuberculosis (Tb) test during screening\n11. Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.\n12. Subjects with eating disorders.\n13. Ongoing or anticipated use of diabetes medications other than insulin.\n14. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 7 days of screening.\n15. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.\n16. Patients who have participated in previous clinical studies, other than observational studies, will be excluded.\n17. Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.\n18. History or diagnosis of malignancy with the exception of a history of localized basal or squamous cell carcinoma.\n19. Any history of gastroparesis or other severe gastrointestinal disease.\n20. Presence of an allograft.\n21. Diagnosed or self-reported drug or alcohol abuse.\n22. An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.\n23. Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire 2-year duration of the study.\n24. Inability to perform any of the assessments required for endpoint analysis.\n25. Known history of serious allergic reactions, including anaphylaxis to CELZ-201 or its preparation components. Specifically, patients with a prior history of heparin induced thrombocytopenia or any other adverse reaction to heparin, will be excluded.\n26. The investigator believes that participating in the trial is not in the best interest of the patient, or the investigator considers patient unsuitable for enrollment (such as unpredictable risks or subject compliance issues).\n27. Positive for coronavirus disease (COVID)-19 by PCR or evidence of active infection per local institutional standards.\n28. Allergy to iodine contrast or anesthesia\n29. For female subjects: Pregnant, nursing, or planning to become pregnant during the course of entire duration of the study (approximately little over two years) or unwillingness to comply with contraceptive requirements.\n30. For male subjects: Male subjects with a female partner who is planning to become pregnant with the male subject during the entire course of the study or unwillingness to comply with contraceptive requirements.","35 Years",{"count":69,"type":22},18,"INTERVENTIONAL",[72,73],"PHASE1","PHASE2","The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).",[76,77],"Type 1 Diabetes","Diabetes Mellitus, Type 1",[79,80,76],"Recent Onset Type 1 Diabetes","Adult Onset Type 1 Diabetes","RECRUITING","2026-02-17",{"date":84,"type":52},"2026-02-19",{"date":86,"type":52},"2023-04-07",{"date":88,"type":22},"2028-01-31",{"name":57,"class":58},1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":70,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":90},"100520182","phase-1-safety-tolerability-and-effectiveness-of-intramuscular-injection-of-celz-201-ddt-for-the-treatment-of-chronic-lower-back-pain-100520182","NCT06053242","Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease","ADAPT","Inclusion Criteria:\n\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Between 18-80 years of age and may be of either gender or any race.\n* Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise\u002Fphysical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined.\n* Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial.\n* Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of \\>5 on a scale of 0-10.\n* Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices.\n* Any male subject must agree to use contraceptives and not donate sperm during the study.\n* Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.\n\nExclusion Criteria:\n\n* History of cancer in the last five years.\n* Spinal infections and spinal tumors.\n* Renal insufficiency requiring dialysis or an eGFR of less than 60 mL\u002Fmin\u002F1.73m2.\n* ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range.\n* Positive pregnancy test.\n* History of blood cell diseases.\n* Uncontrolled diabetes mellitus - HgA1c \\>8%.\n* Uncontrolled hypertension defined as a systolic blood pressure of \\>140 mmHg or diastolic blood pressure of \\>90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll.\n* Patients known to have any active infection, including infection of the injection site(s), and\u002For any active systemic or local infection.\n* Patients on chronic immunosuppressive transplant therapy. Patients receiving \\\u003C5 mg of Prednisone daily may be included.\n* Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.\n* Recent smoking history or substance abuse (within six weeks).\n* Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA)\n* Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment.\n* Any patient who has received gene therapy in the past.\n* Subjects with an average baseline MED \\>90 mg\u002Fday during the screening period are excluded. The average will be calculated over a 7-day time period.\n* Body Mass Index (BMI) \\> 40 kg\u002Fm2.","80 Years",{"count":101,"type":22},45,[72,73],"The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.",[105,106],"Chronic Low-back Pain","Degenerative Disc Disease","2026-02-11",{"date":109,"type":52},"2026-02-13",{"date":111,"type":52},"2024-05-21",{"date":113,"type":22},"2027-05-01",{"name":57,"class":58},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":97,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":4,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":146,"locationsCount":4},"100603518","celz-201-ddt-for-the-treatment-of-chronic-lower-back-pain-100603518","NCT07137559","CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","Inclusion Criteria:\n\n* Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.\n* No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.\n\nExclusion Criteria:\n\n* Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.\n* Known hypersensitivity to any component of the investigational product.\n\nHow to Request Access:\n\n* Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.\n* Complete and submit FDA Form 3926 to the appropriate FDA review division.\n* Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.","EXPANDED_ACCESS","CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.",[125,126],"Chronic Back Pain","Degenerative Disc Disease Lumbar",[128,129,130,131,132,133,134,135,136,137,138,139,140,141],"CELZ-201-DDT","Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells","Mesenchymal Stromal Cells (MSC)","Chronic Lower Back Pain","Degenerative Disc Disease (DDD)","Lumbar Degeneration","Chronic Pain","Expanded Access","Single Patient IND","Emergency Use IND","Non-Emergency Use IND","Compassionate Use","Regenerative Medicine","Stem Cell Therapy","AVAILABLE","2025-08-14",{"date":145,"type":52},"2025-08-22",{"name":57,"class":58},""]