[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,64,83,105,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100627760","phase-1-safety-and-efficacy-study-of-human-umbilical-cord-mesenchymal-stem-cells-in-preventing-arteriovenous-fistula-stenosis-in-patients-with-end-stage-diabetic-kidney-disease-100627760",false,"NCT07452822","Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diabetic nephropathy with estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin·1.73m²;\n2. Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;\n3. Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;\n4. Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;\n2. Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;\n3. Patients with a history of pacemaker implantation;\n4. Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;\n5. Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;\n6. Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period;\n7. Any other conditions deemed inappropriate by the investigator for enrollment in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis",[28],"Arteriovenous Fistula Stenosis","NOT_YET_RECRUITING","2026-03-01",{"date":32,"type":33},"2026-03-05","ACTUAL",{"date":35,"type":21},"2026-02-20",{"date":37,"type":21},"2028-03-30",{"name":39,"class":40},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100621351","phase-1-safety-and-efficacy-study-of-baff-r-car-t-cells-in-adult-subjects-with-cd19-negative-relapsed-or-refractory-b-cell-lymphoma-100621351","NCT07369492","Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 5\\. ECOG score ≤ 2.\n* 6\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m²\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg\u002FdL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 7\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 8\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9\u002FL.\n* Platelets ≥ 50 x 10\\^9\u002FL.\n* Hemoglobin \\>80g\u002FL.\n* 9\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6\\. History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.",{"count":49,"type":21},30,[24],"The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.",[53],"B-cell Lymphoma","RECRUITING","2026-02-25",{"date":57,"type":33},"2026-02-27",{"date":59,"type":33},"2026-01-01",{"date":61,"type":21},"2029-01",{"name":39,"class":40},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":63},"100621257","phase-1-safety-and-efficacy-study-of-anti-pd1-armored-cd19-car-t-cells-in-adult-subjects-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100621257","NCT07368270","Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma","A Prospective, Open-label and Single-arm Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Adult subjects (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).\n* 5\\. CD19 positive expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 6\\. ECOG score ≤ 2.\n* 7\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m².\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg\u002FdL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 8\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 9\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9\u002FL.\n* Platelets ≥ 50 x 10\\^9\u002FL.\n* Hemoglobin \\>80g\u002FL.\n* 10\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6.History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.",{"count":49,"type":21},[24],"The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.",[75],"Diffuse Large B Cell Lymphoma","2026-01-26",{"date":78,"type":33},"2026-01-28",{"date":80,"type":21},"2026-01",{"date":61,"type":21},{"name":39,"class":40},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":63},"100587223","phase-3-phase-3-study-of-human-th-sc01-cell-injection-for-treating-perianal-fistulas-in-patients-with-crohns-disease-100587223","NCT06925594","Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Human TH-SC01 Cell Injection in the Treatment of Anal Fistulas in Patients With Non-active\u002FMildly Active Crohn's Disease","Inclusion Criteria:\n\n1. Signed informed consent\n2. Subjects with Crohn's disease diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018)\n3. Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.\n4. Presence of perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n6. American Society of Anesthesiologists (ASA) physical status classification of grade I to grade II.\n7. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.\n\nExclusion Criteria:\n\n1. Subjects allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.\n2. Subjects with active infection evaluated by the investigator\n3. Subjects with active Crohn's disease before drug administration or have not completed the induction-phase treatment.\n4. Subjects with abscess or collections \\>2 cm.\n5. Rectal and\u002For anal stenosis , if this means a limitation for any surgical procedure\n6. Subjects with concurrent active proctitis.\n7. Subjects with other fistulas such as rectum\u002Fanal canal-vaginal fistulas or rectum-bladder fistulas.\n8. Patients have undergone a diverting stoma operation in the past, except for patients have completed stoma closure at least one month before drug administration.\n9. Patients plan to undergo surgery in the perianal area during the trial period due to other diseases other than anal fistula.\n10. Subjects with abnormal laboratory results: liver function: total bilirubin \\>=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\>=2 × ULN; renal function: creatinine clearance below 60 mL\u002Fminute calculated using Cockcroft-Gault formula or by serum creatinine \\>=1.5 × upper limit of normal (ULN).\n11. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.\n12. Subjects with malignant tumors or a history of malignant tumors.\n13. Subjects with congenital or acquired immunodeficiency.\n14. Contraindication to MRI scan\n15. Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.\n16. Subjects received stem cell treatment within two years prior to screening.\n17. Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks.\n18. Patient undergone major surgical operations (such as orthopedic surgery, abdominal surgery) within one month before drug administration, or Patient plan to receive surgeries during the study period (except for the surgeries required by the procedures of this trial).\n19. Patients with a history of drug abuse or alcoholism (Criteria for alcoholism: having a long-term drinking history of more than 5 years, with the amount of ethanol equivalent to ≥40g\u002Fd for men and ≥20g\u002Fd for women, or having a history of heavy drinking within 2 weeks, with the amount of ethanol equivalent to \\>80g\u002Fd. The conversion formula for the amount of ethanol (g) = the amount of alcohol consumed (ml) × the ethanol content (%) × 0.8).\n20. Pregnant or lactating women.\n21. Patients with a history of diverting ostomy, except those who have undergone stoma reversal at least 1 month prior to drug administration.\n22. Other diseases or conditions that the investigator deems inappropriate for participating in this clinical trial, such as poor subject compliance and the expectation of being unable to complete follow-up and evaluation.",{"count":91,"type":21},228,[93],"PHASE3","The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.",[96],"Crohn's Disease","2025-04-11",{"date":99,"type":33},"2025-04-13",{"date":101,"type":33},"2025-03-20",{"date":103,"type":21},"2028-06-28",{"name":39,"class":40},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100587224","phase-1-evaluate-the-distribution-and-dynamic-behavior-of-nuclide-labeled-th-sc01-cells-in-vivo-in-patients-with-radiation-proctitis-100587224","NCT06925607","Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis","A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis","Inclusion Criteria:\n\n1. Signed informed consent\n2. Good physical condition (WHO performance status score 0-1).\n3. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors\n4. Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.\n5. The LENT-SOMA score was ≥1 during the screening period.\n6. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.\n\nExclusion Criteria:\n\n1. Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.\n2. Patients with allergic constitution or severe systemic autoimmune diseases.\n3. Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.\n4. Pregnant or lactating women.\n5. Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.\n6. Patients with a LENT-SOMA score of 4 during the screening period.\n7. Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.\n8. Patients with uncontrolled tumors, tumor recurrence or metastasis.\n9. Subjects received any investigational drug within 3 months prior to the screening.\n10. Subjects received stem cell treatment.\n11. Participants considered inappropriate to participate in this clinical trial","80 Years",{"count":5,"type":21},[24],"A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis",[117],"Radiation Proctitis","2025-04-07",{"date":99,"type":33},{"date":121,"type":21},"2025-04",{"date":123,"type":21},"2026-12",{"name":39,"class":40},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":63},"100549804","phase-1-umbilical-cord-derived-mesenchymal-stem-cells-injection-for-chronic-radiation-proctitis-100549804","NCT06438809","Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Inclusion Criteria:\n\n1. Fully understand and sign the informed consent form;\n2. Age ≥18 years and \\\u003C80 years;\n3. Good physical condition (WHO performance status score 0-1);\n4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;\n5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;\n6. Screening period LENT-SOMA score ≥1;\n7. Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.\n\nExclusion Criteria:\n\n1. Patients with severe liver or kidney dysfunction during the screening period;\n2. Patients with severe congestive heart failure or coronary artery disease during the screening period;\n3. Patients with allergic constitution or severe systemic immune diseases;\n4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;\n5. Pregnant patients;\n6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;\n7. Patients with a screening period LENT-SOMA score of 4;\n8. Patients with tumor recurrence or metastasis;\n9. Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;\n10. Other situations deemed unsuitable for inclusion in this study by the investigator.","79 Years",{"count":134,"type":21},24,[24,25],"A Phase I\u002FII study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.",[138],"Chronic Radiation Proctitis","2024-06-20",{"date":141,"type":33},"2024-06-21",{"date":143,"type":33},"2024-05-24",{"date":145,"type":21},"2025-05",{"name":39,"class":40},""]