[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100657560","phase-2-alt001-in-patients-with-ischemic-stroke-in-the-sequelae-stage-100657560",false,"NCT07841496","ALT001 in Patients With Ischemic Stroke in the Sequelae Stage","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase II Clinical Study to Evaluate the Efficacy and Safety of ALT001 in Patients With Ischemic Stroke in the Sequelae Stage","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Male or female participants aged 18 to 80 years, inclusive (determined at the time of signing the informed consent form);\n2. A history of acute ischemic stroke confirmed by CT or MRI, with the most recent stroke occurring ≥180 days and no more than 5 years prior to enrollment;\n3. Unilateral limb weakness, with a total Fugl-Meyer Motor score ≤90;\n4. Modified Ashworth Scale score ≤2;\n5. Premorbid mRS ≤1 (i.e., independence in daily living prior to the most recent stroke);\n6. On a stable-dose standard treatment for secondary prevention of ischemic stroke (antiplatelet agents, statins, etc.) for at least 1 month prior to enrollment;\n7. Participants must be willing and able to participate in the study, sign the informed consent form, and commit to completing all study-related procedures and visits in accordance with the protocol.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from this study:\n\n1. The culprit lesion of the most recent stroke is a posterior circulation infarct on imaging;\n2. Baseline head CT or MRI showing malformations, tumors, abscesses, or other major non-vascular brain diseases (e.g., multiple sclerosis, dementia, Parkinson's disease, and other neurodegenerative diseases);\n3. A cerebrovascular or cardiovascular event within the past 3 months, such as transient ischemic attack (TIA) or acute coronary syndrome (ACS);\n4. History of recurrent seizures or epilepsy;\n5. Allergic constitution (allergies to multiple drugs and foods), history of severe allergic\u002Fhypersensitivity reactions, or, in the investigator's judgment, potential allergy to the investigational drug or any of its components (e.g., history of allergy to protein-based drugs);\n6. At screening: positive for hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal (ULN) (if HBsAg is negative, HBV-DNA testing is not required); positive for hepatitis C antibody (anti-HCV) with HCV-RNA above the ULN (if anti-HCV is negative, HCV-RNA testing is not required); positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidum antibody;\n7. Severe hepatic impairment (defined as ALT ≥3 × ULN or AST ≥3 × ULN); severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.73 m²); severe heart failure (New York Heart Association \\[NYHA\\] class III-IV); or coagulation disorders or a history of systemic bleeding;\n8. Poorly controlled blood glucose or blood pressure despite systematic treatment (HbA1c ≥8.5%; systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg);\n9. At screening, severe autoimmune diseases, myeloproliferative disorders, leukemia or lymphoma, malignant tumors, fractures, or severe scoliosis that, in the investigator's judgment, would affect the study evaluation;\n10. Significant cognitive impairment (per MMSE: ≤19 for the illiterate group, ≤22 for the primary school group, ≤26 for the junior high school and above group \\[\\>8 years of education\\]), or other unstable psychiatric conditions that, in the investigator's judgment, render the participant unsuitable for the study (including suicidal ideation, untreated major depression, etc.), or aphasia (aphasia severity grade 0) such that the participant cannot understand and\u002For comply with the study procedures;\n11. Women who are pregnant or breastfeeding, or participants planning to conceive during the treatment period or within 3 months after treatment discontinuation;\n12. Alcohol dependence or a history of drug abuse within 6 months prior to screening that, in the investigator's judgment, renders the participant unsuitable for this study;\n13. Use of neuroprotective agents within 14 days prior to randomization, such as butylphthalide, edaravone, edaravone dexborneol, urinary kallidinogenase, citicoline, cerebroprotein hydrolysate, etc., or use of traditional Chinese medicine preparations with an indication of stroke;\n14. Participation in another clinical trial with use of any other investigational drug or device within 3 months prior to screening; or prior receipt of stem cell therapy or gene therapy;\n15. Patients who, in the investigator's judgment, are unsuitable for participation in this study (e.g., clinically significant abnormalities on physical examination or laboratory tests).","ALL","18 Years","80 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II, randomized, double-blind, placebo-controlled, multicentre clinical study to evaluate the efficacy and safety of ALT001 in patients with ischemic stroke in the sequelae stage (≥180 days and ≤5 years after the most recent event). A total of 200 participants will be randomized 1:1:1:1 to receive ALT001 at 65 μg\u002Fday, 130 μg\u002Fday, or 260 μg\u002Fday, or matching placebo, by intravenous infusion once daily (over \\~60 minutes) using a 14-day-on \u002F 14-day-off cycle for 3 cycles (12 weeks) in the double-blind (DB) period, followed by an optional open-label extension (OLE) period of 3 additional cycles. The primary endpoint is the change from baseline in the Fugl-Meyer Assessment (FMA) motor score at Week 12.",[27],"Ischemic Stroke in the Sequelae Stage",[27,29],"Phase II","NOT_YET_RECRUITING","2026-09-20",{"date":33,"type":34},"2026-09-25","ACTUAL",{"date":36,"type":21},"2026-09-21",{"date":38,"type":21},"2027-10-31",{"name":40,"class":41},"Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100657019","phase-2-a-phase-ii-study-of-alt001-in-patients-with-amyotrophic-lateral-sclerosis-als-100657019","NCT07833618","A Phase II Study of ALT001 in Patients With Amyotrophic Lateral Sclerosis (ALS)","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of ALT001 in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. Participants or their guardians must be able to understand the procedures and methods of this study, communicate adequately with the investigator, be willing to strictly comply with the clinical trial protocol to complete the study, and voluntarily sign a written informed consent form, or have informed consent signed by a legally authorized representative.\n2. Age 18 to 75 years (inclusive of both boundaries), of either sex.\n3. Diagnosis of definite or probable ALS according to the revised El Escorial criteria of the World Federation of Neurology for amyotrophic lateral sclerosis, including both familial and sporadic ALS patients.\n4. Forced vital capacity (FVC) ≥ 50% of predicted at the screening visit.\n5. Total ALSFRS-R score ≥ 30 and ≤ 40 prior to enrollment.\n6. If receiving riluzole or edaravone treatment before enrollment, participants must have been on a stable dose for ≥ 30 days prior to Day 1 of this study, and must maintain that dose until the final study visit.\n\nExclusion Criteria:\n\n1. Have other known diseases associated with motor neuron dysfunction that may confound or obscure the diagnosis of ALS.\n2. History of alcohol dependence or drug abuse within 6 months prior to screening, judged by the investigator to be unsuitable for participation in this study.\n3. Apparent cognitive impairment (MMSE scale: ≤19 for the illiterate group, ≤22 for the primary school group, and ≤26 for the junior high school and above group \\[\\>8 years of education\\]), or other unstable psychiatric disorders that the investigator considers unsuitable for participation (including suicidal intent, untreated major depression, etc.).\n4. Continuous use of non-invasive ventilation (NIV), diaphragm pacing system, or invasive ventilation (tracheostomy) at screening.\n5. Severe autoimmune diseases, myeloproliferative disorders, leukemia or lymphoma, malignant tumors, fractures, or severe scoliosis at screening, which the investigator considers would affect study evaluation.\n6. Other severe and\u002For uncontrolled major organ or unstable systemic diseases, including but not limited to uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), severe congestive heart failure, uncontrolled hypertension, uncontrolled active infection, severe hepatic, renal or other severe metabolic diseases, or severe gastrointestinal diseases.\n7. Positive hepatitis B surface antigen (HBsAg) with HBV-DNA \\> upper limit of normal (if HBsAg is negative, HBV-DNA testing is not required); positive hepatitis C virus (HCV) antibody with HCV-RNA \\> upper limit of normal (if anti-HCV is negative, HCV-RNA testing is not required); positive human immunodeficiency virus (HIV) antibody; or positive Treponema pallidum test.\n8. Pregnant or lactating women, and those planning to conceive during the medication period or within 3 months after stopping the medication.\n9. Participated in another interventional clinical study within 4 weeks prior to this study; received stem cell or exosome therapy within 1 year, or previously received ASO drug treatment or gene therapy.\n10. Judged by the investigator to be unsuitable for participation in this study (e.g., significantly clinically significant abnormalities in physical examination or laboratory tests).","75 Years",{"count":52,"type":21},150,[24],"ALT001 is an allogeneic unrelated human umbilical cord mesenchymal stem cell-derived protein complex under investigation for the treatment of amyotrophic lateral sclerosis (ALS). This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 dose-ranging study in patients with ALS.\n\nApproximately 150 participants will be randomized 1:1:1 to receive ALT001 1.0 μg\u002Fkg, ALT001 2.0 μg\u002Fkg, or matching placebo by intravenous infusion during the 24-week double-blind (DB) treatment period. During the OLE period, the active treatment groups will continue to receive their original dose under blinded conditions, whereas the placebo group will undergo re-randomization in a 1:1 ratio to receive 1.0 or 2.0 μg\u002Fkg ALT001.\n\nThe primary objective is to evaluate the dose-response relationship and efficacy of ALT001 at 1.0 and 2.0 μg\u002Fkg and to determine the recommended dose for subsequent studies. Secondary objectives include assessment of biomarkers related to efficacy and exploration of changes in cytokines, immune function, proteomics, and immunogenicity (anti-drug antibodies, ADA), as well as evaluation of the safety of ALT001.",[56],"Amyotrophic Lateral Sclerosis (ALS)","2026-09-17",{"date":59,"type":34},"2026-09-22",{"date":61,"type":21},"2026-09-01",{"date":63,"type":21},"2028-12-31",{"name":40,"class":41},""]