[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100612936","phase-1-immune-cell-therapy-for-advanced-solid-tumors-100612936",false,"NCT07260058","Immune Cell Therapy for Advanced Solid Tumors","Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. The participant must voluntarily participate in the study and provide written informed consent。\n2. Age ≥ 18 years, male or female.\n3. Histologically and\u002For cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.\n4. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.\n5. Life expectancy ≥ 3 months.\n6. Has not received any other cellular immunotherapy within 3 months prior to enrollment.\n7. Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.\n8. Adequate organ function, defined as follows:\n\nHematology:\n\nWhite Blood Cell (WBC) count \\> 3.5 × 10⁹\u002FL Lymphocyte count \\> 0.9 × 10⁹\u002FL Monocyte count \\> 0.16 × 10⁹\u002FL Absolute Neutrophil Count (ANC) \\> 1.5 × 10⁹\u002FL Platelet (PLT) count \\> 75 × 10⁹\u002FL Hemoglobin (HB) \\> 75 g\u002FL Blood Biochemistry： Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)\n\nCoagulation:\n\nProthrombin Time (PT) and International Normalized Ratio (INR) ≤ 1.5 × ULN\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion\u002Fwash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).\n2. Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.\n3. History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.\n4. Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.\n5. Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).\n6. Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> NYHA (New York Heart Association) Class III, or severe arrhythmia.\n7. Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count \\> 15×10⁹\u002FL; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).\n8. Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.\n9. History of drug allergy.\n10. Pregnant or lactating women; OR women of childbearing potential or men with pregnant partners who are unwilling to use adequate contraception during the planned trial period (from the screening visit until 120 days after the last study treatment).\n11. History of organ transplantation.\n12. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.",[27,28,29,30,31],"Lung Cancer (Locally Advanced or Metastatic)","Liver Cancer (Locally Advanced or Metastatic)","Colorectal Cancer (Locally Advanced or Metastatic)","Breast Cancer (Locally Advanced or Metastatic)","Advanced Solid Tumors",[31,33,34,35,36,37,38,39,40],"Metastatic Lung Cancer","Metastatic Liver Cancer","Metastatic Colorectal Cancer","Metastatic Breast Cancer","Autologous Immune Cell Therapy","Dendritic Cell Vaccine","CIK Cells","NK Cells","NOT_YET_RECRUITING","2025-11-20",{"date":44,"type":45},"2025-12-02","ACTUAL",{"date":47,"type":20},"2025-12-01",{"date":49,"type":20},"2027-12-31",{"name":51,"class":52},"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.","INDUSTRY",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":80,"locationsCount":4},"100610789","phase-1-clinical-research-on-stem-cell-therapy-for-parkinsons-disease-100610789","NCT07232147","Clinical Research on Stem Cell Therapy for Parkinson's Disease","Clinical Study on the Safety, Tolerance and Preliminary Efficacy of Human Mesenchymal Stem Cell Therapy for Parkinson's Disease","Inclusion Criteria:\n\nThe participants must meet all of the following criteria to be included in this study:\n\n1. The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;\n2. At the time of signing the informed consent, the participants must be aged 18 or above and under 75 years old, with no gender restrictions;\n3. During the screening process, the participants must have had primary Parkinson's disease for at least 5 years, have a confirmed medical history record and meet the diagnostic criteria for primary Parkinson's disease as defined by the International Parkinson and Movement Disorder Society (MDS);\n4. During the screening, according to the MDS-UPDRS scoring scale, the Hoehn-Yahr classification of the \"off\" period of drug treatment is 2 to 4;\n5. During the screening, the score of the third part of the MDS-UPDRS in the \"off\" period must be greater than 30;\n6. During the screening, the stable duration of Parkinson's disease and the stable duration of the optimized drug dosage must be at least 4 weeks, and the duration of levodopa use must be at least 1 year;\n7. During the screening, the participants must have a response to levodopa treatment, and the levodopa loading test must be positive;\n8. The participants must experience a decline in the efficacy of anti-Parkinson's disease treatment, which affects their quality of life;\n9. The participants must have good compliance and be able to cooperate with the completion of the assessment items of the trial; For participants with reproductive potential and their partners, they must be free from pregnancy plans for at least 2 weeks before the screening to at least 1 year after the administration of the drug, and must agree to take effective non-drug contraceptive measures during the trial (such as condoms, non-drug intrauterine devices, etc.), except for those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.\n\nExclusion Criteria:\n\nIf the subjects meet any of the following criteria, they will not be included in this study:\n\n1. Allergic to the study drug or its excipients, or allergic to similar drugs of the study drug, or have a history of severe allergies (including any food allergy or drug allergy);\n2. Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;\n3. Have a known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive), or acquired immunodeficiency syndrome-related diseases, or positive HIV serological test results;\n4. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;\n5. Previously diagnosed with secondary or atypical Parkinson's syndrome caused by drugs, metabolic disorders, or other reasons;\n6. Previously diagnosed with epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological diseases;\n7. Have new or unstable mental symptoms within 1 year before screening (such as mental confusion, severe depression, or tendencies towards self-harm\u002Fsuicide);\n8. Have a history of dementia or severe cognitive dysfunction; or have obvious dementia or cognitive dysfunction at screening; the 1.1 part of the MDS-UPDRS score at screening is \\> 3; due to dementia, the subject's compliance is affected, diary cannot be accurately recorded, and\u002For the informed consent cannot be signed;\n9. Have other serious systemic diseases at the time of screening;\n10. Have any history of malignant tumors in the past;\n11. Are participating in other clinical trials, or have participated in other clinical studies within 3 months before administration and received intervention treatment;\n12. Have active infections at the screening period, and still need systemic application of antibiotics, antifungal, antiviral treatment at baseline and the infection has not been controlled;\n13. Have a history of stroke, unstable angina pectoris, or myocardial infarction attack within 6 months before screening;\n14. Have a history of schizophrenia or other severe mental disorders, drug or alcohol abuse;\n15. Pregnant or lactating women; Subjects deemed unsuitable for participation in the study by the investigator's comprehensive assessment.",true,"75 Years",{"count":63,"type":20},20,[23],"This study, through different administration methods, adopted a randomized, double-blind, placebo-controlled trial design to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with Parkinson's disease, explore their initial effectiveness and the relationship between biological active factors and therapeutic efficacy. The \"Clinical Study on the Treatment of Parkinson's Disease with Human Umbilical Cord Mesenchymal Stem Cells\" of this study is expected to provide clinical trial evidence for the development of safe and effective clinical cell therapies for patients with Parkinson's disease.",[67,68,69],"Parkinson Disease (PD)","Neurodegenerative Diseases","Movement Disorders",[71,72,73,74],"Parkinson's disease(PD)","Umbilical cord mesenchymal stem cells (hUC-MSCs)","Stem cell therapy","Safety and efficacy","2025-11-13",{"date":77,"type":45},"2025-11-18",{"date":47,"type":20},{"date":49,"type":20},{"name":51,"class":52},""]