[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Huishan Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100635377","phase-1-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-the-treatment-of-primary-ovarian-insufficiency-100635377",false,"NCT07551895","Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency","A Phase I\u002FⅡ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Primary Ovarian Insufficiency","HS_SW01","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Age ≥18 to \\\u003C40 years, with oligomenorrhea or amenorrhea \\>4 months;\n3. Serum baseline FSH \\>25 U\u002FL (at least two measurements, interval \\>4 weeks);\n4. Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;\n5. No fertility requirement and adherence to strict contraception.\n\nExclusion Criteria:\n\n1. Individuals with childbearing plans or those who are pregnant.\n2. Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).\n3. Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.\n4. Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.\n5. Primary amenorrhea.\n6. Uterine malformations.\n7. Iatrogenic or drug-induced ovarian insufficiency.\n8. Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.).\n9. Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery.\n10. Complicated with endometriosis.\n11. Severe functional impairment of major organs or coagulation disorders.\n12. Active venous or arterial thromboembolic disease within the past 6 months.\n13. Severe hepatic or renal insufficiency, etc.\n14. Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment.\n15. Prior treatment with mesenchymal stem cells less than 3 months before enrollment.\n16. Uncontrolled hypertension (\\>150\u002F100 mmHg).\n17. Any of the following conditions within 3 months prior to enrollment:\n\n    1. Major trauma or major surgery (including joint surgery), or anticipated need for major surgery during the study period, which in the investigator's opinion poses unacceptable risk to the participant;\n    2. Receipt of plasma exchange or extracorporeal photopheresis;\n    3. Participation in any other interventional clinical trial.","FEMALE","18 Years","40 Years",{"count":21,"type":22},21,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS\\_SW01 cells injection) in patients with Primary Ovarian Insufficiency (POI).\n\nParticipants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.",[29],"Primary Ovarian Insufficiency (Poi)",[31,32],"Primary Ovarian Insufficiency","MSC","NOT_YET_RECRUITING","2026-04-22",{"date":36,"type":37},"2026-04-27","ACTUAL",{"date":39,"type":22},"2026-04-15",{"date":41,"type":22},"2027-12-31",{"name":43,"class":44},"Shenzhen Huishan Biotechnology Co., Ltd.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":15,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":4},"100634149","phase-1-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-the-treatment-of-systemic-sclerosis-100634149","NCT07535931","Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis","A Phase I\u002FⅡ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form.\n2. Age 18 to 65 years, inclusive, male or female.\n3. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria.\n4. Diagnosis of diffuse cutaneous systemic sclerosis at screening, with disease duration ≤5 years (disease onset defined as the time of initial SSc diagnosis).\n5. Prior treatment with at least two of the following: corticosteroids, immunosuppressants, or biologic agents, and a modified Rodnan skin score (mRSS) between 10 and 30, inclusive.\n6. Female subjects must meet one of the following:\n\n   1. Of non-childbearing potential, defined as at least one year postmenopausal or surgically sterilized; or\n   2. Of childbearing potential and agree to use effective contraception from the signing of informed consent through at least 6 months after the last dose of study drug, with a negative serum pregnancy test at screening.\n\nExclusion Criteria:\n\n1. At screening, the patient's percent predicted forced vital capacity (FVC) is \\\u003C50%.\n2. Previously diagnosed with moderate or severe pulmonary arterial hypertension, or systolic pulmonary artery pressure \\>45 mmHg measured by echocardiography at screening.\n3. Presence of newly onset or worsening of pre-existing clinical symptoms requiring hospitalization as judged by the investigator prior to screening, including the following:\n\n   ① Myocardial infarction, stroke, scleroderma renal crisis, severe intestinal disease, or uncontrolled severe hypertension (≥160\u002F100 mmHg) with newly onset or worsening of pre-existing clinical symptoms within 6 months.\n\n   ② Unstable ischemic heart disease, uncontrolled cardiac arrhythmia, heart failure (New York Heart Association Class III\u002FIV), left ventricular ejection fraction \\\u003C50% by echocardiography, renal insufficiency, or renovascular hypertension within 3 months.\n4. Presence of other autoimmune connective tissue diseases other than systemic sclerosis at screening, except for patients with secondary Sjögren's syndrome who are permitted to participate in this trial.\n5. Any of the following laboratory abnormalities at screening:\n\n   ① Hematologic abnormalities: hemoglobin \\\u003C90 g\u002FL; white blood cell count \\\u003C3.0×10\\^9 \u002FL; absolute neutrophil count \\\u003C1.5×10\\^9 \u002FL; platelet count \\\u003C90×10\\^9 \u002FL.\n\n   ② Hepatic abnormalities: ALT or AST \\>3× upper limit of normal (ULN); total bilirubin \\>3× ULN.\n\n   ③ Renal abnormalities: estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², or any uncontrolled, clinically significant laboratory abnormality that may interfere with data interpretation or subject participation.\n6. Positive test for human immunodeficiency virus antibody (anti-HIV-Ab), active syphilis, active hepatitis C (positive for HCV antibody with detectable HCV-RNA), or positive for HBsAg with detectable HBV-DNA at screening; or history of severe active or recurrent bacterial, viral, fungal, parasitic, or other infections at screening.\n7. Receipt of inactivated or live-attenuated vaccine within 2 months prior to enrollment.\n8. Any of the following within 3 months prior to enrollment:\n\n   ① Major trauma or major surgery (including joint surgery), or need for major surgery during the study period that, in the investigator's opinion, would pose an unacceptable risk to the subject.\n\n   ② Treatment with plasmapheresis or extracorporeal photopheresis.\n\n   ③ Participation in any other interventional clinical trial.\n9. Prior treatment with stem cell-based therapy less than 3 months before enrollment.\n10. History of any malignancy within 5 years prior to enrollment, except for adequately treated or resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n11. Intolerance or contraindication to the study treatment, including any of the following:\n\n    ① Allergy to albumin contained in the excipients of the investigational product.\n\n    ② Absence of peripheral venous access.\n12. Heavy smoking, heavy drinking, or drug abuse within 12 months prior to screening or during the screening period:\n\n    ① Heavy smoking defined as an average of ≥5 cigarettes per day within 3 months prior to screening.\n\n    ② Heavy drinking defined as consumption of more than 14 units of alcohol per week within 3 months prior to screening (1 unit = 350 mL of beer, 45 mL of liquor, or 150 mL of wine).\n\n    ③ Drug abuse defined as a history of drug addiction or drug abuse.\n13. Plan to father or bear children within at least 6 months following the last dose, or unwilling to use effective contraception with their partner, or plan to donate sperm or eggs.\n14. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.","ALL","65 Years",{"count":21,"type":22},[25,26],"The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS\\_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy.\n\nParticipants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.",[58],"Systemic Sclerosis (SSc)",[60,32],"systemic sclerosis","2026-04-16",{"date":63,"type":37},"2026-04-21",{"date":65,"type":22},"2026-04-10",{"date":41,"type":22},{"name":43,"class":44},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":15,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":53,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":86,"locationsCount":4},"100634050","phase-1-a-phase-i-clinical-trial-for-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-the-treatment-of-ankylosing-spondylitis-100634050","NCT07534644","A Phase I\u002FⅡ Clinical Trial for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Ankylosing Spondylitis","A Phase I\u002FⅡ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis","Inclusion Criteria:\n\n1. Age 18 to 65 years, inclusive, male or female.\n2. Voluntarily sign the informed consent form and comply with the requirements of this study protocol.\n3. Participants must have a documented diagnosis of ankylosing spondylitis (AS) based on the modified 1984 New York criteria, as follows: (a) Inflammatory back pain for ≥3 months, improving with activity but not relieved by rest;; (b) Limited spinal motion in the lumbar spine (sagittal and frontal planes); (c) chest expansion reduced relative to normal values for age and sex. (d):Sacroiliitis on imaging: bilateral grade II-IV or unilateral grade III-IV. Diagnosis of AS requires fulfillment of criterion (d) plus any one of criteria (a)-(c). The diagnosis must be confirmed at both the screening and baseline visits.\n4. Participants must have active AS at screening and baseline, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4.\n5. Participants must have received conventional therapy and, prior to randomization, must meet at least one of the following criteria for the following criteria, as confirmed by the investigator: (a) inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs): ≥4 weeks of continuous therapeutic-dose NSAID if one agent used; or ≥2 weeks of therapeutic-dose NSAID for each of ≥2 agents; (b) intolerance to NSAIDs: Discontinuation of NSAIDs due to treatment-related adverse events (e.g., allergic reactions, gastrointestinal symptoms or signs); the 4-week treatment duration is not required. (c) Contraindication to NSAID therapy: History of NSAID allergy, active gastrointestinal ulcer, bleeding, or other contraindications.\n6. Participants who have previously received at least two biologic disease-modifying antirheumatic drugs (bDMARDs) must have received recommended doses for at least 12 weeks prior to randomization with inadequate response, or have been intolerant to at least one bDMARD treatment (e.g., unable to continue due to adverse drug reactions, allergic reactions, or other reasons).\n7. Participants receiving concomitant oral corticosteroids or NSAIDs must be on a stable dose for at least 14 days before the baseline visit. Participants receiving conventional synthetic DMARDs (cDMARDs) must be on a stable dose for at least 28 days prior to the baseline visit.\n8. Female participants must: Be of non-childbearing potential, defined as postmenopausal for at least 1 year or surgically sterilized; OR, If of childbearing potential, agree to use strict contraceptive measures from the time of signed informed consent through at least 6 months after the last dose of study drug, and have a negative serum pregnancy test at screening.\n9. Participants must be considered in good general health based on medical history and physical examination performed at screening, as judged by the investigator.\n10. Participants must voluntarily agree to receive disease education and be willing to maintain correct posture and perform appropriate physical exercise.\n11. Participants must be willing and able to complete all study procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any component of this product;\n2. History of significant drug abuse or alcohol dependence currently or within the past 2 years;\n3. Complete rigidity of the spine in the trial participant;\n4. Undergone bone\u002Fjoint\u002Fsynovectomy surgery within 3 months prior to screening, or planned to undergo joint or spinal surgery during the trial period;\n5. Participation in another clinical trial within 3 months prior to screening, or planned participation in another clinical trial;\n6. Severe infection indicated by clinical and radiological data; patients positive for HIV, hepatitis C, syphilis, etc.; patients with tumors or a tendency to develop tumors; patients with severe cardiac, pulmonary, hepatic, renal, hematologic, endocrine, or other systemic diseases; patients with epilepsy or psychiatric disorders;\n7. Received mesenchymal stem cell therapy within less than 3 months prior to screening;\n8. Breastfeeding women, women planning to become pregnant during the study period, or men planning to father a child;\n9. Significant laboratory abnormalities:\n\n(1) Hemoglobin \\\u003C 90 g\u002FL in males, \\\u003C 85 g\u002FL in females; (2) White blood cell count \\\u003C 3 × 10\\^9\u002FL; (3) Platelet count \\\u003C 90 × 10\\^9\u002FL; (4) AST or ALT \\> twice the upper limit of normal; (5) Other laboratory results considered markedly abnormal by the investigator; 10.Presence of active infection, including acute, chronic, or local infections (e.g., sepsis, abscess, opportunistic infection, invasive fungal infection, etc.); 11.Oral antibiotic use within 2 weeks prior to screening, or intramuscular\u002Fintravenous antibiotic treatment for infection within 4 weeks prior to screening, or a history of severe infection within 6 months prior to screening (the investigator should assess the potential risk of enrollment based on individual clinical history); 12.History of recurrent herpes zoster, history of Listeria infection, history of reticuloendothelial fungal disease, or other chronic or recurrent infections; 13.Presence of one or more of the following conditions:\n\n1. Inability to perform activities of daily living, requiring a wheelchair or bedridden due to limited mobility;\n2. Severe cardiac, pulmonary, hepatic, or renal dysfunction;\n3. Uncontrolled hypertension (150\u002F100 mmHg);\n4. History of congestive heart failure (New York Heart Association Class III\u002FIV);\n5. History of acute myocardial infarction or unstable angina within 12 months prior to screening;\n6. Cerebrovascular or cardiovascular event within 3 months prior to dosing (myocardial infarction, ischemic or hemorrhagic stroke (excluding lacunar infarction), severe arrhythmia, deep vein thrombosis, etc.);\n7. Any clinically significant respiratory disease, including but not limited to chronic obstructive pulmonary disease, asthma, interstitial pneumonia, bronchiectasis, pleural effusion;\n8. History of demyelinating disease or clinical suspicion of such disease, including but not limited to multiple sclerosis, Guillain-Barré syndrome;\n9. Unstable diabetes mellitus without stable dosing control within 4 weeks prior to screening (HbA1c \\\u003C 6.5% at screening);\n10. Other inflammatory arthritis or rheumatic diseases (other than AS) that may affect the evaluation of clinical efficacy, including but not limited to rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gouty arthritis;\n11. Any neurological, psychiatric, or other systemic disease that may affect the evaluation of clinical efficacy;\n12. History of malignancy within the past 5 years (excluding cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ);\n13. History of lymphoma or lymphoproliferative disease; 14.Concomitant use of the following medications:\n\n(1) Use of glucocorticoids, except for oral prednisone at a daily dose ≤ 10 mg or equivalent dose of other corticosteroids, with the dose stable for at least 4 weeks; (2) Patients who discontinued leflunomide and received cholestyramine (8 g three times daily) for 2 weeks must have a 4-week washout period before screening. Patients who discontinued leflunomide without taking cholestyramine must have a 12-week washout period from the last dose of leflunomide to screening; (3) Use of alkylating agents within 12 months prior to screening; (4) Intra-articular, intramuscular, or intravenous injection of corticosteroids within 4 weeks prior to screening; 15.The investigator considers the patient unsuitable for enrollment in this trial.",{"count":76,"type":22},18,[25,26],"The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS\\_SW01 cells injection) in patients with Ankylosing Spondylitis.\n\nParticipants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.",[80],"Ankylosing Spondylitis",[80,32],{"date":83,"type":37},"2026-04-20",{"date":65,"type":22},{"date":41,"type":22},{"name":43,"class":44},""]