[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wuhan Optics Valley Vcanbiopharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100568133","phase-1-a-phase-iii-trial-of-vum02-injection-for-steroid-refractory-acute-graft-versus-host-disease-sr-agvhd-treatment-100568133",false,"NCT06677255","A Phase I\u002FII Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VUM02 Injection in the Treatment of Patients With Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD)","ESTEVS-I\u002FII","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible for this trial:\n\n1. Subjects aged 14-70 years (inclusive), male or female;\n2. Subjects who undergone allogeneic hematopoietic stem cell transplantation as indicated for hematological malignant disease, developed with grade II to IV aGvHD and failed standard first-line steroid therapy (that is, SR-aGvHD); 1) Definition of standard first-line steroid \u002Fglucocorticoid therapy: 1 mg\u002Fkg\u002Fday or 2 mg\u002Fkg\u002Fday of Methylprednisolone, or equivalent doses of steroids; 2) According to Thomas' Hematopoietic Cell Transplantation: Stem Cell Transplantation (5th edition), subjects who meet one of the following criteria are considered to have failed the standard first-line steroid \u002Fglucocorticoid therapy:\n\n   * a. Steroid resistance: Progression of aGvHD at Day 3 of first-line steroid therapy, or no improvement in aGvHD at Day 7, or incomplete remission of aGvHD at Day 14;\n   * b. Steroid dependence: failure to taper first-line steroid therapy or reactivation of aGvHD during taper;\n3. Investigator assessment: Expected survival ≥ 3 months;\n4. Clinical manifestations of aGvHD are rash and\u002For persistent nausea, vomiting, and\u002For diarrhea and\u002For cholestasis. For these clinical manifestations, other etiologies such as drug rash, intestinal infection, or hepatotoxicity syndrome have been ruled out;\n5. Subjects will be required to receive the investigational product within 3 days of enrollment;\n6. Subjects must give informed consent to the study prior to enrollment, with the subject himself\u002Fherself, or, the subject himself\u002Fherself and his\u002Fher legal guardian (only for subjects \\\u003C18 years of age), voluntarily signing a written informed consent form.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for this trial:\n\n1. Subjects with lung disease who, in the judgment of the investigator, are not appropriate to participate in the study;\n2. Serum virological examination shows positive results for active hepatitis B (hepatitis B core antibody positive and HBV-DNA in peripheral blood higher than the upper limit of normal), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the upper limit of normal), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody;\n3. Patients with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;\n4. Subjects who developed aGvHD after donor lymphocyte infusion therapy for recurrence of underlying hematologic malignancies;\n5. Patients complicated with brain lesion or who, in the judgment of the investigator, present with mental status changes;\n6. For subjects with aGvHD enrolled primarily for gastrointestinal symptoms, cytomegalovirus (CMV) enteritis, transplant-associated thrombotic microangiopathy (TA-TMA), and diarrhea due to gastrointestinal infections could not be ruled out clinically, as assessed by the investigator; pathological diagnostic criteria for CMV enteritis are: Large cells with basophilic inclusions in the intestinal mucosa; positive early\u002Flate CMV antigen by immunohistochemistry; positive CMV nucleic acid PCR in the homogenates of intestinal mucosal;\n7. Patients with coagulation dysfunction requiring anticoagulant therapy or antiplatelet therapy;\n8. Subject's renal function: Creatinine clearance \\\u003C30mL\u002Fmin; creatinine clearance is calculated using the Cockcroft-Gault formula: Ccr(ml\u002Fmin)=\\[(140-age)×body weight(kg)\\]\u002F(72×blood creatinine (mg\u002FdL), calculated results × 0.85 for females), and attention should be paid to the unit of creatinine during calculation of creatinine clearance;\n9. ECOG PS score \\> 3;\n10. Subjects who have evidence within 6 months prior to enrollment that suggests that they have other diseases or their physiological conditions may interfere with the evaluation results of this study, or have serious life-threatening complications, including but not limited to uncontrolled infection, pulmonary hypertension, severe cardiac insufficiency (NYHA Class III and IV), unstable angina pectoris or acute myocardial infarction, refractory hypertension (defined as the simultaneous use of 3 different types of antihypertensive drugs \\[one of which is the diuretic\\], and blood pressure remains higher than 160\u002F110 mmHg) (subject to the inpatient medical record diagnosis);\n11. Patients with active malignant solid tumor within 5 years before the study, except radically treated cervical cancer, localized prostate cancer in situ and non-melanoma skin cancer;\n12. Patients suffering from mental and neurological diseases and unable to correctly express their wishes;\n13. Patients who have received ≥ 1 therapy for aGvHD other than hormonal and protocol-recommended second-line agents prior to the study (subjects who received prophylactic drugs for aGvHD prior to the study may be included in this study);\n14. Patients with a known history of severe allergy to blood components or blood products, or to heterologous proteins;\n15. Breastfeeding women, or female subjects who have plans to become pregnant or donate eggs from the start of the study to the follow-up period, and male subjects (or their partners) who have plans to father a child or donate sperm from the start of the study to the follow-up period and are unwilling to take contraceptive measures;\n16. Patients who are not appropriate for participation in this clinical study as judged by the investigator;\n17. Patients who have participated in other clinical studies within the past one month.","ALL","14 Years","70 Years",{"count":21,"type":22},149,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","It is a phase I\u002FII clinical study to evaluate the safety, tolerability and preliminary efficacy of VUM02 Injection in patients with acute graft-versus-host disease (aGvHD) who have failed systemic steroid therapy. VUM02 Injection (human umbilical cord-derived mesenchymal stromal \u002Fstem cells, hUC-MSC) is an off-the-shelf allogeneic cell therapy product comprising culture-expanded mesenchymal stromal \u002Fstem cells derived from the human umbilical cord tissue. The product is cryopreserved with the cell concentration of 5 x 10\\^6 cells\u002FmL. Patients with grade II to IV aGvHD who have failed systemic steroid therapy (i.e. patients with steroid-refractory aGvHD (SR-aGvHD)), will be recruited into this study. This study consists of two phases, a dose-escalation phase (phase I) and a dose-expansion phase (phase II).",[29],"Steroid-refractory Acute Graft-versus-host Disease",[31,32,33,34],"acute graft-versus-host disease","Mesenchymal stromal \u002Fstem cells","SR-aGvHD","VUM02 Injection","NOT_YET_RECRUITING","2024-11-05",{"date":38,"type":39},"2024-11-06","ACTUAL",{"date":41,"type":22},"2025-01",{"date":43,"type":22},"2028-12",{"name":45,"class":46},"Wuhan Optics Valley Vcanbiopharma Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100533823","phase-1-safety-tolerability-and-efficacy-of-vum02-injection-in-treatment-of-idiopathic-pulmonary-fibrosis-ipf-100533823","NCT06230822","Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)","A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis","DEVIF-I","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible for this trial:\n\n1. Gender unrestricted, aged between 40 and 75 years old (inclusive);\n2. Diagnosed with IPF according to the 2022 Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS\u002FERS\u002FJRS\u002FALAT Clinical Practice Guideline.\n3. In the 3 months prior to administration, determined by the investigator to have stable disease, with diffusing capacity of the lung for carbon monoxide (DLCO) between 30% and 79% of the predicted value (adjusted for Hb), FVC\u002Fpredicted ≥50%, and forced expiratory volume in one second (FEV1)\u002FFVC ≥0.70;\n4. Allowed to enroll are the patients who have been treated according to the current standard treatment plan for IPF and have maintained the treatment for at least 3 months;\n5. Good compliance, able to understand and cooperate with pulmonary function test procedures, willing to participate voluntarily in the trial according to the protocol requirements, and understand and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for this trial:\n\n1. Allergic to any ingredient of the product;\n2. Suffering from interstitial lung diseases (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs (such as amiodarone, bleomycin, or methotrexate); other types of occupational lung diseases; granulomatous lung diseases; systemic diseases including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases, or a history of prior pulmonary resection;\n3. During the screening period, having any of the following pulmonary diseases: asthma, pulmonary embolism, pneumothorax; lung cancer, obstructive bronchitis, or other active lung diseases; a known history of immune system diseases (such as thymic diseases, systemic lupus erythematosus); acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n4. Chest HRCT during the screening period shows emphysema area \\> fibrosis area;\n5. Previously received stem cell therapy or intolerant to cell therapy;\n6. Received unstable standard of care for IPF within the 3 months prior to screening;\n7. Used non-biological drugs with cell proliferation inhibition or immunosuppressive\u002Fimmunomodulatory effects during the 3 months prior to screening, such as Mycophenolate Mofetil, cyclophosphamide, tacrolimus, and JAK inhibitors, as well as other Chinese herbal medicines with immunomodulatory effects;\n8. Used biologics such as rituximab, TNF-α monoclonal antibodies, and IFN-γ monoclonal antibodies within the 6 months prior to screening;\n9. Used anticoagulant drugs, sildenafil, bosentan, macitentan, imatinib, and other drugs for treating IPF within the 4 weeks prior to screening;\n10. Participated in interventional clinical studies within the 3 months or within the half-life of 5 drugs (whichever is longer) before screening;\n11. Hospitalized 2 or more times in the past year due to acute exacerbation of IPF;\n12. Had a lung infection within the past month;\n13. Had a history of invasive or non-invasive mechanical ventilation, or currently require oxygen therapy (oxygen therapy time \\>15 h\u002Fd);\n14. Smoked within the past 3 months or cannot quit smoking during the trial;\n15. The expected survival period may be less than 1 year judged by investigator;\n16. Laboratory tests meet any of the following criteria: white blood cell count less than 3.5×109\u002FL or neutrophils less than 1.5×109\u002FL for any reason; hemoglobin (HGB) ≤90 g\u002FL; fibrinogen (FIB) ≤0.5×LLN; alanine aminotransferase (ALT) \\>2×ULN, aspartate aminotransferase (AST) \\>2×ULN, total bilirubin (TBIL) \\>1.5×ULN, direct bilirubin (DBIL) \\>1.5×ULN, blood creatinine (Cr) \\>1.5×ULN;\n17. Evidence suggests that the subject currently has digestive system, urinary system, cardiovascular system, hematological system, nervous system, psychiatric, or metabolic diseases that may affect safety, such as severe kidney disease requiring blood dialysis or peritoneal dialysis; advanced hepatitis or cirrhosis; severe heart failure (NYHA Grade III and IV); poorly controlled hypertension (≥180\u002F100 mmHg); severe pulmonary heart disease or pulmonary arterial hypertension considered by the investigators to affect the evaluation of the trial results;\n18. Have various malignant tumors or a history of malignant tumors;\n19. 12-lead electrocardiogram shows severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, and atrial flutter) or degree II and above atrioventricular block;\n20. Positive results in serological tests (HBsAg, HCV antibodies, HIV antibodies, syphilis spirochete antibodies), among which carriers of hepatitis B virus, stable patients with hepatitis B (DNA titer ≤2000 IU\u002FmL or copy number \\\u003C1000 copies\u002FmL) after drug treatment, and cured patients with hepatitis C (negative HCV RNA) can be enrolled after being judged eligible by the investigator;\n21. Pregnant or lactating women, or those with a positive result in the screening period for beta-human chorionic gonadotropin (β-HCG) testing; or male subjects of childbearing potential and female subjects of childbearing age who are unable and unwilling to take effective non-drug contraceptive measures during the study and 6 months after the end of the study;\n22. Subjects deemed inappropriate for entry into this study by the investigator.","40 Years","75 Years",{"count":59,"type":22},9,[25],"This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10\\^7 cells per 10 mL per bag (5 x 10\\^6 cells\u002FmL). This study is a multiple-dose tolerability study following the \"3+3\" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.",[63],"Idiopathic Pulmonary Fibrosis","RECRUITING","2024-02-18",{"date":67,"type":39},"2024-02-20",{"date":69,"type":22},"2024-02",{"date":71,"type":22},"2026-12",{"name":45,"class":46},4,""]