[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591115":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":39,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":33,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":88,"overallStatus":42,"whyStopped":33,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"XS228 for injection","EXPERIMENTAL","The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in Subacute Spinal Cord Injury participants.",[13],"Biological: Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells","Description:\n\nThe Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in subacute spinal cord Injury participants.For SAD,the participants will single intrathecal injection with the dose level as 5×10\\^7 cells 、1.5×10\\^8 cells. For MAD, the participants will intrathecal injection of XS228 in Day 1, Day15, Day 29, Day 43 under the dose level of 5×10\\^7 cells、1.5×10\\^8 cells.Dose escalation followed a rule-based 3+3 design.\n\nXS228 is an investigational, allogeneic cell therapy product composed of motor neuron progenitor cells (MNPCs) derived from human induced pluripotent stem cells (iPSCs). This advanced therapy medicinal product (ATMP) is being developed for the treatment of subacute spinal cord injury and represents a novel approach in regenerative medicine.",[9],[21,22],"XS228 Cell Injection","XS228",[24],{"name":25,"affiliation":26,"role":27},"Limin Rong, prof and M.D","Third Affiliated Hospital, Sun Yat-Sen University","PRINCIPAL_INVESTIGATOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Michael LEE","CONTACT","+86 21 64027719",null,"CEO@xellsmart.com",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Mao Pang, prof and M.D","+86-020-85252015","pangmao6@mail.sysu.edu.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Third Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510630","China","CN",{"type":49,"coordinates":50},"Point",[51,52],113.25,23.11667,{"lat":52,"lon":51},[55],{"name":25,"role":31,"phone":56,"phoneExt":33,"email":57},"02085253333","ronglm@mail.sysu.edu.cn",{"type":59,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[61],{"name":26,"class":62},"OTHER","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":74,"type":75},12,"ESTIMATED","INTERVENTIONAL",[78],"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",[81,82,83,84,85,86,87],"Spinal Cord Injury","Safety","Clinical Trials","Efficacy","Induced Pluripotent Stem Cells","Human Motor Neuron Progenitor","Transplantation",[89,90,91,92,85,93,87],"spinal cord injury","safety","efficacy","clinical trials","Human motor neuron progenitor","2025-11-19",{"date":96,"type":97},"2025-11-25","ACTUAL",{"date":99,"type":97},"2025-07-02",{"date":101,"type":75},"2028-05-30",{"name":5,"class":6},1]