[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,67,101,123,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100637524","phase-1-the-safety-tolerability-and-efficacy-of-dopaminergic-neural-progenitor-cells-xs411cn-cell-injection-for-the-treatment-of-multiple-system-atrophy-parkinsonian-variant-msa-p-100637524",false,"NCT07617012","The Safety, Tolerability, and Efficacy of Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P).","Phase I Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Stereotactic Intracerebral Transplantation of Human Allogeneic Induced Pluripotent Stem Cell-derived Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P).","Inclusion Criteria:\n\n* Male or female, aged 30 to 75;\n* According to the 2022 International Movement Disorders Association's Diagnostic Criteria for Multiple System Atrophy, the patient meets the clinically confirmed and clinically probable diagnostic criteria for multiple system atrophy, and is diagnosed with Parkinson's type multiple system atrophy.\n* MSA movement disorder symptoms have been present for no more than 5 years;\n* The participant or their legal guardian must agree to the research protocol and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.\n* Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI\u002FPET examination, cranial CT\u002FMRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.\n* Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.\n* Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI\u002FPET examination, cranial CT\u002FMRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.\n* Patients with schizophrenia, severe depression (Hamilton Depression Rating Scale (HAMD-17) score ≥24), or severe anxiety (Hamilton Anxiety Rating Scale (HAMA) score ≥29);\n* Patients with schizophrenia, severe depression (Hamilton Depression Rating Scale (HAMD-17) score ≥24), or severe anxiety (Hamilton Anxiety Rating Scale (HAMA) score ≥29);\n* Patients who meet the diagnostic criteria for dementia (DSM-IV or ICD-10) ;\n* Those who test positive for serious infectious diseases such as hepatitis A, active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody, or Treponema pallidum (TP) antibody;\n* Any history of malignant tumors, excluding cured basal cell carcinoma and\u002For squamous cell carcinoma of the skin, cervical cancer in situ, or ductal carcinoma of the breast;\n* Those with uncontrolled autoimmune diseases;\n* Those who have been vaccinated or plan to be vaccinated during the trial within the three months prior to screening, such as with COVID-19, influenza, shingles, or pneumococcal vaccines;\n* Women of childbearing age with a positive pregnancy test result before administration; women of childbearing age, unsterilized male participants whose partners are of childbearing age, and who have not used effective contraception for at least 6 months from the date of signing the ICF to the date of administration ; female participants who do not agree to never donate eggs and male participants who do not agree to never donate sperm from the date of signing the ICF to at least 6 months after administration.\n* Patients who participated in other drug or medical device clinical trials within one month prior to receiving treatment;\n* A history of long-term alcoholism or drug abuse;\n* Any other situation that researchers deem unsuitable for participation in the research.",true,"ALL","30 Years","75 Years",{"count":21,"type":22},3,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase I Study to Assess the Safety, Tolerability and Efficacy of dopaminergic neural progenitor cells (XS411CN cell injection) for the treatment of multiple system atrophy Parkinsonian variant (MSA-P).",[28],"the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P)","NOT_YET_RECRUITING","2026-05-26",{"date":32,"type":33},"2026-06-01","ACTUAL",{"date":35,"type":22},"2026-06-15",{"date":37,"type":22},"2028-06-30",{"name":39,"class":40},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100605764","phase-1-clinical-study-to-evaluate-xs411-in-treatment-of-early-onset-parkinsons-disease-100605764","NCT07166757","Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Human Allogeneic Induced Pluripotent Stem Cell-derived Dopaminergic Neural Progenitor Cell Injection in the Treatment of Early-onset Parkinson's Disease","Inclusion Criteria:\n\n* 18 years old ≤ age of onset ≤ 50 years old, diagnosed with EOPD (meeting the MDS 2015 clinical diagnostic criteria for Parkinson's disease );\n* 18 years old ≤ age at enrollment ≤ 70 years old , male\u002Ffemale;\n* Disease duration ≥ 5 years;\n* Phase I: the modified Hoehn-Yahr grade in the off-phase is 3-4 (including the critical value) , and the modified Hoehn-Yahr grade in the on-phase is ≤3 ; Phase II: the modified Hoehn-Yahr grade in the off-phase is 2-4 (including the critical value) , and the modified Hoehn-Yahr grade in the on-phase is ≤3;\n* Off-period MDS -UPDRS-III score \\>30;\n* Positive L-dopa stress test;\n* The patient is unable to adequately control motor fluctuations even with a stable dose of medication recommended in the \"Guidelines for the Treatment of Parkinson's Disease in China (Fourth Edition)\" ;\n* Patients received stable doses of anti-PD drugs for at least 4 weeks before administration;\n* Able to accept surgical anesthesia, suitable for neurosurgery under anesthesia, and able to undergo brain CT \u002FMRI examination;\n* Participants agree to postpone any other elective neurosurgery until the completion of the 24-month follow-up study;\n* Participants agreed not to participate in any other clinical studies within 24 months after dosing;\n* Participants or their legal representatives understand and comply with the research procedures, voluntarily participate and sign the ICF\n\nExclusion Criteria:\n\n* Non-primary PD or Parkinson's superimposed syndromes ;\n* Patients are in the late stages of PD and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and\u002For unpredictable or widely fluctuating symptoms;\n* Have previously undergone neuronucleotomy, deep brain stimulation (DBS), striatal surgery, extrapyramidal surgery, stereotactic brain surgery, or other brain surgery; or who have undergone other surgical procedures that the investigator determined would affect participation in this study; or who have surgical contraindications\n* Patients currently receiving L-dopa intestinal instillation, apomorphine injection, or continuous daily infusion of anti-PD drugs;\n* Patients who had used botulinum toxin, phenol, subarachnoid injection of baclofen, or received interventional treatment for dystonia or spasticity within 6 months before medication;\n* Have used glucocorticoids or immunosuppressive drugs for a long time within 3 months before the screening visit;\n* Those who have received cell therapy before;\n* Patients who received electroconvulsive therapy within 30 days before administration;\n* Those who have received or plan to receive vaccines during the trial within 3 months before screening, such as vaccines for novel coronavirus pneumonia (COVID-19), influenza, herpes zoster, and pneumococcal vaccine;\n* Those with a history of mental illness who are judged by the researchers to be unsuitable for study participation; or those with severe suicidal ideation currently or within the year before screening or any history of suicide attempts within the past 2 years;\n* Those with active epilepsy or currently taking anti-epileptic drugs;\n* Those with a history of dementia or severe cognitive impairment; or those with obvious dementia or cognitive impairment at screening; dementia may affect participants' poor compliance, inability to accurately record diaries, and \u002F or inability to sign the ICF;\n* Severe anxiety at screening;\n* Patients whose previous head CT\u002FMRI examinations showed brain injuries such as brain trauma, cerebral vascular malformation, hydrocephalus, brain tumors, or abnormal brain imaging of the striatum and other brain regions, which significantly increased the surgical risk;\n* Those with uncontrolled autoimmune diseases;\n* Patients with a history of severe cardiovascular and cerebrovascular diseases;\n* Patients with other serious systemic diseases;\n* During the screening period, patients have severe arthritis, limp, severe sequelae of stroke, severe osteoporosis, or a history of severe trauma within 1 month (such as hip or lower limb fractures), which may affect the study evaluation as assessed by the researchers;\n* Patients with malignant tumors or a history of malignant tumors;\n* Patients with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before signing the ICF, or patients who cannot stop taking antiplatelet drugs or other anticoagulants for at least 10 days before surgery;\n* Previous history of abnormal coagulation function;\n* Patients with lab result abnormalities during screening include;\n* Allergic to the drugs used in the study;\n* Are pregnant or breastfeeding, or plan to become pregnant during the study;\n* Female participants of fertile potential must have a positive pregnancy test result before dosing; female participants of fertile potential, or male participants who are not sterilized and whose partners are fertile, must not take effective contraceptive measures from the time they sign the ICF until at least 24 months after dosing; female participants must not agree to not donate eggs from the time they sign the ICF until at least 24 months after dosing, and male participants must not agree to not donate sperm from the time they sign the ICF until at least 24 months after dosing;\n* Participants who are currently participating in other clinical trials, or have participated in other clinical studies and received intervention treatment within 1 month before administration;\n* Those who are considered by the researchers to have poor compliance;\n* Any other situation that the researcher deems to jeopardize the safety of the participants or affect the study evaluation.","18 Years","70 Years",{"count":51,"type":22},90,[25,53],"PHASE2","This study is a Phase I\u002FII clinical study to evaluate the safety, tolerability, and efficacy of XS411 in the treatment of EOPD. The study consists of two phases: Phase I and Phase II.\n\nPhase I study is planned to be conducted in patients with EOPD, using a single-arm, open-label, traditional \" 3+3 \" dose-escalation design, aiming to investigate the safety, tolerability and preliminary efficacy of XS411 in the treatment of EOPD and to determine the RP2D.\n\nPhase I study enrolls 6-12 patients with EOPD. Two dose cohorts (3-6 patients\u002Fdose cohort) are planned: 9×10⁶ cells \u002Fpatient and 1.8 ×10⁷ cells \u002Fpatient. Each participant will receive a single injection of XS411. Each participant in each dose cohort will be observed for at least 28 days after dosing . If no DLTs occur and the investigator has no other safety concerns for that participant, the next participant in that dose cohort will be enrolled.\n\nPhase II study is planned for patients with EOPD, using a randomized, double-blind, sham-controlled, parallel-group design . The study will investigate the efficacy and safety of XS411 in the treatment of EOPD . Phase II study currently plans to enroll 81 patients with EOPD. The patients will be randomly assigned in a 2:1 ratio to either the experimental or control group. Participants in the experimental group will receive a single injection of XS411 in combination with an immunosuppressant at the RP2D determined during the Phase I dose-escalation phase (which may be adjusted based on the Phase II study results). The control group will receive a sham procedure in combination with an immunosuppressant sham.",[56],"Parkinson Disease (PD)","RECRUITING","2025-12-25",{"date":60,"type":33},"2025-12-29",{"date":62,"type":33},"2025-09-22",{"date":64,"type":22},"2029-03-30",{"name":39,"class":40},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":87,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":66},"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","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.","65 Years",{"count":76,"type":22},12,[25],"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",[80,81,82,83,84,85,86],"Spinal Cord Injury","Safety","Clinical Trials","Efficacy","Induced Pluripotent Stem Cells","Human Motor Neuron Progenitor","Transplantation",[88,89,90,91,84,92,86],"spinal cord injury","safety","efficacy","clinical trials","Human motor neuron progenitor","2025-11-19",{"date":95,"type":33},"2025-11-25",{"date":97,"type":33},"2025-07-02",{"date":99,"type":22},"2028-05-30",{"name":39,"class":40},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":74,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":66},"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":109,"type":22},60,[53],"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.",[80,81,83,113,84,85,86,114],"Clinical Trial","RCT",[80,81,90,116,84,92,86,114],"clinical trial",{"date":95,"type":33},{"date":119,"type":22},"2028-05-25",{"date":121,"type":22},"2031-05-26",{"name":39,"class":40},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":19,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":66},"100602039","phase-1-the-safety-tolerability-and-preliminary-efficacy-of-derived-motor-neuron-progenitor-cells-xs228cn-in-subjects-with-amyotrophic-lateral-sclerosis-100602039","NCT07118319","The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis","A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. 18-75 years of age (inclusive of 18 and 75 years), regardless of gender;\n2. Diagnosed of definite or probable ALS according to the revised EI Escorial criteria;\n3. Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%);\n4. Patients with birth-potential (both male and female) must agree to use effective non-drug contraceptive measures from the time of signing the informed consent until 6 months after the conclusion of the trial;\n5. Volunteer to participate in the clinical study, understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out;\n2. Baseline body mass index (BMI) \\\u003C 18.5 kg\u002Fm²;\n3. Primary lateral sclerosis presenting only with upper motor neuron symptoms;\n4. Significant psychiatric disorders that the investigator assesses may affect evaluation;\n5. Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis;\n6. Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation;\n7. Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled;\n8. Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis;\n9. Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation;\n10. Poorly controlled hypertension;\n11. Previous or detected cardiac abnormalities;\n12. A history of cirrhosis, chronic hepatitis, or liver function at screening;\n13. A history of chronic kidney disease;\n14. Previous history of bleeding, abnormal clotting, or being treated with anticoagulation;\n15. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening;\n16. History of severe trauma or surgery and may affect the assessment judged by investigator;\n17. Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure.\n18. Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy;\n19. Have participated in other clinical trials within 3 months prior to screening;\n20. Pregnant or breastfeeding women;\n21. Subject who is judged by the investigator to be unsuitable for the clinical trial.",{"count":76,"type":22},[25],"A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis",[134],"Amyotrophic Lateral Sclerosis (ALS)","2025-11-17",{"date":137,"type":33},"2025-11-21",{"date":139,"type":33},"2025-09-15",{"date":141,"type":22},"2028-09-30",{"name":39,"class":40},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":150,"maxAge":19,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":66},"100599152","phase-1-the-safety-and-tolerability-of-xs411cn-injection-in-treatment-of-primary-parkinsons-disease-100599152","NCT07080775","The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease","A Phase I Clinical Study on the Safety and Tolerability of iPSC-Derived Dopaminergic Neural Progenitor Cell Injection Via Stereotaxic Brain Transplantation for the Treatment of Primary Parkinson's Disease","Inclusion Criteria:\n\n1. Male or female, aged between 50 and 75 years old;\n2. Diagnosed as 'clinically established PD' consistent with MDS clinical Diagnostic Criteria for Parkinson's disease,\n3. A minimum of 5 years since diagnosis;\n4. Hoehn- Yahr score during the off-time is 3 to 4;\n5. The subjects with an average of at least 2.5 hours of \"off time\" per day;\n6. Stable anti-PD therapy for at least 1 month before screening;\n7. Anti-PD treatment was once effective, but the efficacy has declined significantly or drug-induced motor complications have occurred, affecting the quality of life;\n8. Positive levodopa challenge test (MDS-UPDRS-III score improvement from off- state to on- state \\> 30%);\n9. At least three months before the first administration, the subject should have completed all vaccinations as recommended by local authorities;\n10. The results of complete blood count meet the following conditions: ANC ≥ 2.0×109 \u002FL, WBC ≥ 4.0×109 \u002FL, PLT≥ 100×109 \u002FL, HGB ≥ 10g\u002FdL\n11. The patient or his\u002Fher legal guardian agree to accept the study and signed the informed consent form in writing.\n\nExclusion Criteria:\n\n1. Parkinsonian syndrome or secondary Parkinson's disease (Atypical Parkinson's syndrome (Parkinson's plus syndrome, secondary Parkinson's syndrome, hereditary degenerative Parkinson's syndrome);\n2. Patients are in advanced stages of Parkinson's disease and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and\u002For unpredictable or widely fluctuating symptoms;\n3. Severe cognitive impairment (MMSE\\\u003C24, poor compliance due to dementia, inability to accurately record diaries, and\u002For inability to sign informed consent;\n4. Those with a history of severe mental illness, or those with severe suicidal tendencies as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), or those with suicidal ideation in the past 12 months, or those who have attempted suicide in the past 5 years;\n5. Patients with severe brain atrophy, space-occupying lesions, hydrocephalus, cerebral vascular malformations as indicated by head CT\u002FMRI, and those with structural abnormalities that may affect transplantation or increase surgical risks as determined by the investigators;\n6. Currently with active internal bleeding; or arterial puncture at a site that is difficult to stop bleeding within 1 week before screening; or gastrointestinal or urinary bleeding within 3 weeks before screening;\n7. History of striatal or extrapyramidal surgery, including but not limited to deep brain stimulation (DBS) surgery and globus pallidus lesion;\n8. Coagulation abnormalities;\n9. Abnormal liver and kidney function laboratory tests during the screening period;\n10. The patient is currently receiving or has previously received the following treatments:\n\n    * Use of benzodiazepines at a dose level equal to or higher than the recommended dose in Package Insert for more than 4 weeks cumulatively since one month before enrollment, immunosuppressants (except for the immunosuppressants to be used in this study), or antipsychotics within 3 months before treatment;\n    * Use of botulinum toxin, phenol, subarachnoid baclofen injection, or interventional treatment for dystonia or spasticity within 6 months before treatment;\n    * Have a history of epilepsy or use anti-epileptic drugs for prevention;\n    * Received cell therapy within 3 months before screening;\n11. Contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), MRI or PET examinations;\n12. Those with the following abnormalities in the past or detected (if any of the following is met, they will be excluded):\n\n    * Evidence of congestive heart failure or history of end-stage cardiovascular disease;\n    * Severe arrhythmias and poorly controlled arrhythmias;\n    * Clinically significant electrocardiogram abnormalities during the screening or baseline period;\n    * History of unstable angina or acute myocardial infarction within the past 3 months;\n    * Diabetic patients with poor glycemic control;\n    * Hypertensive patients with poorly controlled blood pressure;\n13. Patients with active infection during the screening period (except mild local skin infection) that need antibiotic, antifungal, or antiviral treatment but infection is still not under control;\n14. The presence of severe lung diseases during the screening period;\n15. Patients with uncontrolled autoimmune diseases;\n16. During the screening period, patients have severe arthritis, limp, severe sequelae of stroke, severe osteoporosis, or history of severe trauma within 1 month, etc., which the investigators assess may affect the evaluations;\n17. Any history of malignancy, excluding cured basal cell carcinoma and\u002For squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma of the breast;\n18. Serious infectious diseases;\n19. Pregnant or lactating women, women who plan to become pregnant during the study and within 6 months after the end of the study, or women who are unwilling to use effective contraceptive measures;\n20. Patients who have participated in other clinical studies of drugs or medical devices within 3 months before treatment;\n21. Have a long history of alcoholism or drug abuse;\n22. Patients with a history of severe allergies or allergies to investigational drugs and immunosuppressants;\n23. Any other conditions that the investigator considers unsuitable for participation in the study.\n24. Severe depression\n25. Hallucinations, and hallucinations still exist after optimizing Parkinson's medications\n26. Patients have undergone MRI-guided focused ultrasound thalamotomy\n27. Used immunosuppressants within 3 months, except for the immunosuppressants to be used in this study","50 Years",{"count":76,"type":22},[25],"This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease",[155],"Parkinson's Disease","2025-09-04",{"date":158,"type":33},"2025-09-11",{"date":160,"type":33},"2025-08-05",{"date":162,"type":22},"2029-08-30",{"name":39,"class":40},""]