[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"induced-pluripotent-stem-cells\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:induced-pluripotent-stem-cells":31},{"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":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100591115","phase-1-safety-and-early-efficacy-of-ipsc-derived-motor-neuron-progenitor-cells-xs228-in-subacute-spinal-cord-injury-a-phase-i-trial-100591115",false,"NCT06976229","Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial","A Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\nAge: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator.","ALL","18 Years","65 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury",[27,28,29,30,31,32,33],"Spinal Cord Injury","Safety","Clinical Trials","Efficacy","Induced Pluripotent Stem Cells","Human Motor Neuron Progenitor","Transplantation",[35,36,37,38,31,39,33],"spinal cord injury","safety","efficacy","clinical trials","Human motor neuron progenitor","RECRUITING","2025-11-19",{"date":43,"type":44},"2025-11-25","ACTUAL",{"date":46,"type":44},"2025-07-02",{"date":48,"type":21},"2028-05-30",{"name":50,"class":51},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":52},"100591018","phase-2-efficacy-of-ipsc-derived-motor-neuron-cells-xs228-in-subacute-spinal-cord-injury-a-phase-ii-randomized-controlled-trial-100591018","NCT06974968","Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial","A Phase II Clinical Study Evaluating the Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\n* Age: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator",{"count":61,"type":21},60,[63],"PHASE2","Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.\n\nStudy Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.\n\nWho Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).\n\nStudy Plan:\n\nPhase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.\n\nFollow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.\n\nWhat Researchers Are Looking For:\n\nPrimary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.\n\nSecondary Goals:\n\nImprovement in ASIA Impairment Scale (AIS) grade (e.g., from \"complete\" to \"incomplete\" paralysis).\n\nRecovery of sensation and bladder\u002Fbowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.\n\nWhy This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.",[27,28,30,66,31,32,33,67],"Clinical Trial","RCT",[27,28,37,69,31,39,33,67],"clinical trial","NOT_YET_RECRUITING",{"date":43,"type":44},{"date":73,"type":21},"2028-05-25",{"date":75,"type":21},"2031-05-26",{"name":50,"class":51}]