[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599152":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"4.5×10^6 cells \u002F bilateral putamen","EXPERIMENTAL",null,[13],"Drug: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection",{"label":15,"type":10,"description":11,"interventionNames":16},"9.0×10^6 cells \u002F bilateral putamen",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"1.8×10^7 cells \u002F bilateral putamen",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection","5.0×10\\^7 cells\u002FmL, injection, once, 12 months",[18,9,15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Michael LEE","CONTACT","+86 21 64027719","CEO@xellsmart.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing Tiantan Hospital","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":51,"email":52},"Feng TAO","+86 10 59976611","+86 1391112533","happyft@sina.com",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[56],{"name":34,"class":57},"OTHER","100599152","phase-1-the-safety-and-tolerability-of-xs411cn-injection-in-treatment-of-primary-parkinsons-disease-100599152",false,"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","ALL","50 Years","75 Years",{"count":69,"type":70},12,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","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",[76],"Parkinson's Disease","2025-09-04",{"date":79,"type":80},"2025-09-11","ACTUAL",{"date":82,"type":80},"2025-08-05",{"date":84,"type":70},"2029-08-30",{"name":5,"class":6},1]