[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iRegene Therapeutics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,72,92,115,136],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100600811","phase-1-this-clinical-trial-is-designed-to-evaluate-the-safety-tolerability-feasibility-and-preliminary-efficacy-of-nouvneu001-human-dopaminergic-progenitor-cells-injection-in-patients-with-parkinsons-disease-100600811",false,"NCT07102342","This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.","A Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.","NouvNeu001-01","Inclusion Criteria:\n\nAge\n\n• Male or female patient must be 30 to 75 years of age inclusive, at the time of signing the informed consent form (ICF).\n\nType of Patient and Disease Characteristics\n\n* Diagnosis of PD between past 4 to 20 years (meet MDS 2015 clinical diagnostic criteria for PD).\n* H-Y staging (Appendix III) for \"OFF\" episodes is 2.5-4.0.\n* MDS-UPDRS-III score \\> 35, and positive for the Acute levodopa challenge test (ALCT) (improvement \\> 30% for MDS UPDRS-III staging from OFF episodes to ON episodes) over two screening period visits. Baseline scores will be computed as the means of two screening period visits.\n* No significant change in UPDRS-III scores between the two visits during the screening period.\n* Patients who take stable doing of dopamine drug for at least 4 weeks prior to receiving the study drug.\n* No significant change in dose and dosing schedule of the prescribed medicines for PD during the screening period.\n* Medically suitable for neurosurgery under general anesthesia.\n* Acceptable laboratory test values during screening and prior to transplantation (Day 0):\n\n  * Absolute neutrophil count ≥ 2.0 × 109\u002FL\n  * White blood cell count ≥ 4.0 × 109\u002FL\n  * Platelet count ≥ 100 × 109\u002FL\n  * Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN)\n  * Total bilirubin ≤ 1.5 x ULN\n  * Serum creatinine ≤ 1.5 x ULN\n  * eGFR ≥ 50 mL\u002Fmin\u002F1.73 m2\n* Agree to postpone any additional neurosurgical procedures, including DBS, until completion of the 12-month follow-up study (unless recommended by a neurologist).\n* Agree not to participate in any other therapeutic intervention study within 24 months after neurosurgery.\n* Able to participate in all study visits and evaluations, including brain\u002Fspine MRI, CT and PET scan.\n\nWeight • Body mass index (BMI) within the range of 18\\~32 kg\u002Fm2 (inclusive) with a minimum body weight of 45 kg at screening.\n\nSex and Contraceptive\u002FBarrier Requirements\n\n• Contraceptive use by men and women for 12 months after neurosurgery should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nInformed Consent\n\n* Able to understand the rationale of the clinical trial and sign the ICF. Other Inclusion Criteria\n* Agree not to receive COVID-19 vaccine within 14 days before neurosurgery, and not to receive any other vaccine within 30 days after neurosurgery\n\nExclusion Criteria:\n\nMedical Conditions\n\n* Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, familial parkinsonism) Prior\u002FConcomitant Therapy\n* Patients who have had previous pallidotomy, DBS surgery, striatal or extrapyramidal surgery, brain stereotaxy, prior surgical or radiation therapy to the brain or spinal cord, or other brain surgery; as well as other surgical procedures that, in the investigator's judgment, could interfere with participation in this study.\n* Patients who have a previous head CT\u002FMRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.\n* Patients who have had previous cellular therapy.\n* Patients who have used glucocorticoids for an extended period (≥14 days) and at high doses (equivalent to prednisone ≥ 20 mg\u002Fday or other glucocorticoids at equivalent doses) within 3 months prior to signing the ICF. (excluding topical treatment)\n* Patients who have used immunosuppressive drugs for an extended period (≥14 days) within 3 months prior to signing the ICF.\n* Patients who have used antipsychotics, such as antidepressants, antimanic drugs, etc. within 3 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.\n* Patients who have used botulinum toxin or other drugs for dystonia or muscle spasticity within 6 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.\n\nPrior\u002FConcurrent Clinical Study Experience\n\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies within 3 months prior to the screening\n* Patients with poor compliance based on clinical evaluation of the investigator. Diagnostic Assessments\n* Patients with a history of dementia or a severe cognitive disorder; or those with obvious dementia or congnitive impairment detected during screening; MDS-UPDRS congnitive impairment score (section 1.1) \\> 3 point at screening; or patinets with poor compliance, inability to accurately keep diary, and\u002For inability to sign ICF due to dementia.\n* Severe depression as defined by HAMD ≥ 24 at screening.\n* Severe anxiety as defined by HAMA ≥ 29 at screening.\n* Patients with a history of psychiatric disorders that, in the investigator's opinion, make them unsuitable for participation; or patients with a history of suicidal ideation or suicide attempts within the past year or currently (including actual attempts, interrupted attempts, or failed attempts).\n* Patients with abnormal coagulation (prothrombin time ≥ 1.5 ULN, activated partial thromboplastin time ≥ 1.5 ULN), or abnormal INR at screening.\n* Patients cannot temporarily suspend anti-platelet agents or other anti-coagulant medications at least 5 days prior to investigational drug administration surgery.\n* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to signing the ICF.\n* Patients with current or history of following disease\n\n  * severe heart failure (congestive heart failure of New York Heart Association Class II or above), unstable angina pectoris, and myocardial infarction\n  * severe arrhythmia, including but not limited to second- or third-degree atrioventricular block, or prolonged QT interval.\n  * Long QT Syndrome.\n  * cardiovascular surgery (cardiac, vascular stent surgery, angioplasty).\n  * stroke or transient ischemic attack within 3 months prior to signing the ICF, as determined by the investigator to be unsuitable to participate the study.\n  * subarachnoid hemorrhage\n  * primary mitochondrial disorder, multiple sclerosis, or other neurodegenerative diseases such as Alzheimer's disease\n  * major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis), as determined by the investigator to be unsuitable to participate the study.\n  * previous or current malignant tumors\n  * immune disfunction, including autoimmune disease or immunocompromised state\n  * traumatic brain injury with loss of consciousness and residue neurologic symptoms\n  * active epilepsy or currently on anti-epileptic drugs\n* Hypertensive patients with poorly controlled blood pressure (defined as blood pressure above 160\u002F100 mmHg despite antihypertensive drugs treatment) and patients with severe postural hypotension\n* Diabetic patients with poorly controlled blood glucose (glycosylated hemoglobin \\> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1mmol\u002FL)\n* Patients with clinically significant abnormalities in kidney or liver function at screening.\n* Patient with clinically significant abnormalities in immunological tests at screening\n* Patients with surgical contraindications (such as those with cochlear implant, cardiac pacemaker, cardiac defibrillator, stereotactic nucleus pallidotomy; Patients who have had unilateral or bilateral intraparenchymal implantation of cellular products, or other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications)\n* Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD) (FEV1% \\\u003C 50%)\n* Patients with serious infections, requiring antibiotic treatment within 2 weeks prior to signing the ICF\n* Patients with any active infectious disease, including but not limited to positive for human immunodeficiency virus, SARS Covid-19 virus, syphilis antibody, quantitative HCV-RNA testing, quantitative HBV-DNA testing greater than normal range for test results, or untreated tuberculosis; any other active infection that, in the investigator's opinion, may affect the participant's ability to take part in the study or could impact study outcomes.\n\nOther Exclusion Criteria\n\n* Patients with alcohol or drug addiction\n* Patients with contraindications or a history of allergy to any medicines used during the neurosurgical procedure.\n* Patients with contraindication or a history of allergy to any medicines used during the study, such as immunosuppressants, levodopa, etc, or any of their components; Patients who are allergic to similar drugs or other macrolides.\n* Female of childbearing potential who are not surgically sterilized\u002Fpremenopausal\u002Funwilling to use medically approved effective contraception during the study and lactating women; men who are not surgically sterilized\u002Funwilling to use medically approved effective contraception during the study\n* Patients who have received electric shock therapy within 30 days prior to the investigational drug administration surgery\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies within 3 months prior to the screening\n* Patients with poor compliance based on clinical evaluation of the investigator\n* Patients who are being treated with drugs such as neuroleptics, apomorphine, or levodopa\u002Fcarbidopa infusion therapy\n* Patients with severe dyskinesia in both \"ON\" and \"OFF\" drug states\n* Patients who have received or will receive a live vaccine within 4 weeks prior to the study\n* Patients with significant medical conditions, or with other conditions that, in the opinion of the investigator, are unsuitable to participate in the study","ALL","30 Years","75 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a phase 1\u002F2 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.",[29],"Parkinson Disease",[31,32,33,34],"NouvNeu001","Human Dopaminergic Progenitor Cells Injection","phase 1 study","Dopaminergic Progenitor Cells","RECRUITING","2026-05-07",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":39},"2026-01-12",{"date":43,"type":22},"2032-09",{"name":45,"class":46},"iRegene Therapeutics Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100635260","phase-1-phase-i-clinical-study-of-nouvneu001-injection-for-the-treatment-of-moderate-to-advanced-parkinsons-disease-in-patients-who-have-previously-undergone-deep-brain-stimulation-or-deep-brain-nucleus-lesioning-surgery-100635260","NCT07550374","Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery","Phase I Clinical Study to Evaluate the Safety and Efficacy of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery","Inclusion Criteria:\n\n1. Age ≥18 years and ≤70 years, male or female.\n2. The subject understands and agrees to comply with the study procedures, voluntarily participates, and signs the informed consent form.\n3. Primary Parkinson's disease (meeting the diagnostic criteria of the International Parkinson and Movement Disorder Society \\[MDS\\]), and the subject has previously undergone deep brain stimulation (DBS) or deep brain nucleus lesioning surgery.\n4. With DBS turned off, the MDS Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score in the \"off\" state is ≥30; and the levodopa challenge test is positive (improvement rate in UPDRS-III score ≥30%).\n5. Able to undergo neurosurgery under anesthesia, and able to undergo CT\u002FMRI\u002FPET examinations.\n6. At screening, with DBS turned on, the modified Hoehn and Yahr stage (Appendix 3) in the \"off\" state is between 2.5 and 4 (inclusive), and with DBS turned on, the daily \"off\" time is not less than 2 hours.\n7. Has received stable doses of anti-Parkinson's disease medications for at least 4 weeks prior to administration.\n8. Acceptable laboratory values obtained during the screening period and prior to administration (Day 0): Absolute neutrophil count ≥ lower limit of normal (LLN); White blood cell count ≥ LLN; Platelet count ≥ LLN; AST and ALT ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; eGFR ≥ 50 mL\u002Fmin\u002F1.73 m².\n9. The subject agrees to postpone any other elective neurosurgical procedures until completion of the 12-month follow-up study.\n10. The subject agrees not to participate in any other interventional clinical studies within 12 months after administration.\n11. The subject agrees not to receive any vaccines within 30 days after administration.\n\nExclusion Criteria:\n\n1. Atypical or secondary parkinsonism confirmed by the investigator to be caused by medication, metabolic disorders, or other conditions.\n2. Presence of persistent active infection in the previous brain surgery area, cerebrospinal fluid (CSF) leakage, or unhealed wounds; presence of implanted device malfunction, electrode displacement, etc., which in the investigator's judgment poses a significant risk to the subject or affects evaluation; contraindications to MRI (e.g., intracranial implants, cochlear implants, cardiac pacemaker\u002Fdefibrillator, etc.); any contraindications to surgery or anesthesia as assessed by the investigator; or other surgical conditions that the investigator believes may affect participation in this study.\n3. Significant abnormalities on cranial CT\u002FMRI, including but not limited to: cerebral vascular malformation, vasogenic edema, brain tumor, more than 10 microbleeds, basal ganglia cerebral infarction lesions, etc., which in the investigator's judgment significantly increase surgical risk.\n4. History of severe cardiovascular disease within 1 year prior to screening, including but not limited to: severe heart failure (New York Heart Association Class III or IV, or left ventricular ejection fraction \\\u003C35% by any method), unstable angina pectoris, myocardial infarction, clinically significant conduction abnormalities (e.g., unstable atrial fibrillation), etc., which in the investigator's judgment may increase surgical risk or render the subject unsuitable for participation.\n5. History of malignant tumor, or receipt of cell therapy or gene therapy within 2 years prior to screening.\n6. Active disseminated intravascular coagulation (DIC) or significant bleeding tendency within 3 months prior to signing informed consent, or inability to discontinue antiplatelet or other anticoagulant medications for at least 5 days before surgery.\n7. Long-term (≥14 days) and high-dose (prednisone ≥20 mg\u002Fday or equivalent dose of other glucocorticoids) use of glucocorticoids or immunosuppressants (excluding topical use) within 3 months prior to signing informed consent.\n8. History of psychiatric illness that, in the investigator's judgment, makes the subject unsuitable for participation; or history of suicidal ideation or suicidal attempt (including actual attempt, interrupted attempt, or aborted attempt) within the past year or currently.\n9. Use of botulinum toxin within 6 months prior to signing informed consent.\n10. Active epilepsy or current use of antiepileptic drugs at screening.\n11. History of dementia or severe cognitive impairment; or obvious dementia or cognitive impairment at screening; MDS-UPDRS Part 1.1 (cognitive impairment) score \\>3 at screening; poor compliance, inability to accurately complete diaries, and\u002For inability to sign informed consent due to dementia.\n12. Severe depression, anxiety, or severe dysphagia at screening.\n13. Any of the following abnormal laboratory findings at screening, including but not limited to: Clinically significant abnormalities in coagulation function (prothrombin time ≥1.5 × ULN, activated partial thromboplastin time ≥1.5 × ULN); Clinically significant immunological abnormalities or autoimmune disease, assessed by the investigator as unsuitable for trial participation; Poorly controlled hypertension (defined as blood pressure still \\>160\u002F100 mmHg despite antihypertensive treatment) and severe orthostatic hypotension; Poorly controlled diabetes mellitus (HbA1c \\>9.0%, or fasting plasma glucose \\[FPG\\] ≥11.1 mmol\u002FL).\n14. Other severe systemic diseases, such as cor pulmonale, severe chronic obstructive pulmonary disease (COPD) (FEV1% \\\u003C50%), etc.\n15. Presence of human immunodeficiency virus (HIV) infection, syphilis infection, active hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, tuberculosis infection, or other active infections that the investigator believes may affect the subject's participation in the study or influence study outcomes.\n16. Alcohol dependence, or positive drug abuse screening.\n17. Contraindication or history of allergy to medications used during the study (e.g., tacrolimus, levodopa, etc.) or any of their components; allergy to the above drugs, other macrolide drugs; or allergic constitution (e.g., allergy to two or more drugs or foods).\n18. Women of childbearing age who have not undergone sterilization\u002Fare not postmenopausal\u002Fare unwilling to use medically recognized effective contraception for 2 years after study drug administration, and breastfeeding women; men who have not undergone sterilization\u002Fare unwilling to use medically recognized effective contraception for 2 years after study drug administration.\n19. Receipt of electroconvulsive therapy within 30 days prior to administration.\n20. Currently participating in another clinical trial, or having participated in another clinical study and received interventional treatment within 3 months prior to administration.\n21. Severe dyskinesia in both medication \"on\" and \"off\" states.\n22. Serious illness, or poor compliance as judged by the investigator, or any other condition that the investigator believes may jeopardize subject safety or affect study evaluation.","18 Years","70 Years",{"count":58,"type":22},10,[25],"This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.",[62],"Parkinson's Disease (PD)","NOT_YET_RECRUITING","2026-04-19",{"date":66,"type":39},"2026-04-24",{"date":68,"type":22},"2026-05",{"date":70,"type":22},"2031-07",{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":91,"locationsCount":47},"100615197","phase-1-a-phase-iiii-clinical-study-to-evaluate-nouvneu001-injection-for-multiple-system-atrophy-100615197","NCT07289477","A Phase I\u002FIII Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy","A Phase I\u002FIII Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Intracerebral Putamen Transplantation of NouvNeu001 Injection for Multiple System Atrophy","Inclusion Criteria:\n\n* Aged between 30 and 70 years (inclusive), regardless of gender.\n* The subject understands and agrees to comply with the study procedures and voluntarily provides written informed consent.\n* Diagnosed with pathologically confirmed, clinically established, or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria.\n* Current treatments for core MSA symptoms are inadequately controlled.\n* The duration of MSA-related motor symptoms (parkinsonism and\u002For cerebellar ataxia) is no more than 5 years.\n* Ability to walk without human assistance, defined as being able to take at least 10 steps; the use of assistive devices (e.g., a walker or cane) is permitted.\n* Life expectancy of at least 3 years.\n* The subject agrees not to participate in any other clinical studies for 24 months following the investigational product administration.\n\nExclusion Criteria:\n\n* Neurological diseases\u002Fdisorders other than Multiple System Atrophy, such as Parkinson's disease, Dementia with Lewy Bodies, Essential Tremor, Progressive Supranuclear Palsy, Spinocerebellar Ataxia, Hereditary Spastic Paraplegia, Corticobasal Degeneration, Vascular Parkinsonism, Normal Pressure Hydrocephalus, or Drug-induced\u002FPostencephalitic Parkinsonism.\n* Diagnosis of dementia.\n* Previous or current receipt of other disease-modifying therapies, or participation in clinical trials of other new drugs or novel therapies.\n* Use of medications within the past 3 months that may affect Parkinsonian symptoms, autonomic function, or the evaluation of safety.\n* Presence of clinically significant or unstable medical or surgical conditions that may preclude the safe completion of the treatment or confound the treatment outcomes.\n* History of or undergoing treatment for recurrent stroke.\n* Screening brain MRI shows other significant pathological findings, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter of less than 1 cm do not warrant exclusion).\n* Subjects meeting any of the following criteria indicating advanced disease:\n\nSpeech impairment defined by a score of ≥3 on UMSARS Item 1. Swallowing impairment defined by a score of ≥3 on UMSARS Item 2. Walking impairment defined by a score of ≥3 on UMSARS Item 7. Occurrence of falls more than once per week, defined by a score of ≥3 on UMSARS Item 8.\n\n* History of current substance abuse and\u002For alcohol abuse (within 12 months prior to screening).\n* Known allergy to the investigational product(s); or history of allergy to antibiotics or other drugs.\n* Positive screening results for active viral infection, including Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), Hepatitis B Core Antibodies, or Hepatitis C Virus (HCV).\n* Severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency:\n\nSevere hepatic insufficiency: ALT ≥ 2.0 × upper limit of normal (ULN) or AST ≥ 2.0 × ULN.\n\nSevere renal insufficiency: Serum creatinine ≥ 1.5 × ULN or estimated Glomerular Filtration Rate (eGFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m².\n\nSevere cardiac insufficiency: New York Heart Association (NYHA) Class 3 or 4.\n\n* History of thrombocytopenia within the past three months, other bleeding disorders, or current receipt of anticoagulant therapy (excluding aspirin at a dose ≤ 100 mg per day).\n* Pregnancy, lactation, or planning pregnancy.\n* History of Bipolar Disorder, Major Depressive Disorder, Schizophrenia, or other psychotic disorders.\n* Subjects judged by the investigator to have suicidal ideation at screening, or a suicide attempt within 6 months prior to screening.\n* Contraindications for surgery (e.g., implantation of cochlear implants, pacemakers, defibrillators, history of stereotactic ablation, previous implantation of unilateral\u002Fbilateral similar products) or history of other surgeries within the past 6 months deemed by the investigator to potentially affect this trial, or other neurosurgical contraindications.\n* Clinically significant cardiac disease defined as: myocardial infarction, NYHA Class III or IV heart failure, uncontrolled coronary spasm, severe uncontrolled ventricular arrhythmia, or evidence of acute ischemia or abnormal conduction system on ECG within 6 months prior to enrollment.\n* Diagnosis of malignancy.\n* Family history of congenital or inherited immunodeficiency disorders.\n* Considered by the investigator to have poor compliance.\n* Any other significant disease or condition that, in the investigator's judgment, may jeopardize the subject's safety or interfere with the study assessments.",{"count":80,"type":22},9,[25],"This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Multiple System Atrophy.",[84],"Multiple System Atrophy - Parkinsonian Subtype (MSA-P)","2026-04-13",{"date":87,"type":39},"2026-04-14",{"date":89,"type":39},"2026-01-05",{"date":70,"type":22},{"name":45,"class":46},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":19,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":47},"100595144","phase-2-the-safety-feasibility-and-efficacy-of-nouvneu001-for-parkinsons-disease-100595144","NCT07028632","The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease","A Phase I\u002FII Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease","Inclusion Criteria:\n\n* Age 50-75 years old, male or female\n* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)\n* Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)，Parkinson's disease history of ≥ 4 years\n* Medically suitable for neurosurgery under anesthesia and able to participate in Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan\n* Hoehn-Yahr staging for \"off\" episodes is 2.5 to 4\n* The MDS-UPDRS Part III (MDS-UPDRS-III) score in the \"off\" state \\> 35, and positive for the Acute Levodopa Challenge Test (ALCT)\n* Currently undergoing treatment with levodopa drugs, but with poor control of motor symptoms or reduced efficacy\n* Receive a stable dose of anti-Parkinson's disease drugs for at least 4 weeks before administration\n* Acceptable laboratory test results during screening and prior to transplantation\n* The patients agreed to postpone any other elective neurosurgery, including deep brain stimulation (DBS), until the completion of the 24-month follow-up\n* The patients agreed not to participate in any other interventional clinical studies within 24 months after administration\n* The patients agreed not to receive any vaccines within 30 days after administration\n\nExclusion Criteria:\n\n* Atypical or secondary Parkinson's syndrome to be caused by drugs, metabolic disorders or other reasons\n* The patients who have a previous history of PD-related brain surgery and have been judged by the investigator to pose significant risks or impact the assessment, or patients with contraindications for magnetic resonance imaging, or those who have been assessed by the investigator as having any contraindications for surgery or anesthesia, or patients who have received other surgeries that the investigator consider might affect their participation in this study\n* There were obvious abnormalities in the cranial CT\u002FMRI examination\n* Those who have a history of severe cardiovascular diseases within one year prior to screening\n* Patients with a history of malignant tumors，or those who have received cellular therapy or gene therapy within the five years prior to the screening\n* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery\n* Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF\n* Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently\n* Patients who have used botulinum toxin within 6 months prior to signing the ICF\n* Patients with active epilepsy or currently on anti-epileptic drugs\n* Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \\> 3; poor compliance, inability to accurately keep diary, and\u002For inability to sign ICF due to dementia\n* Patients with severe depression or with severe anxiety during screening\n* Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose\n* Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)\n* There are human immunodeficiency virus (HIV) infection, syphilis infection, and active hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, tuberculosis infection or other active infections that the investigator consider may affect the participation of the patients in the study or affect the study outcome\n* Patients with alcohol addiction or positive for drug of abuse testing\n* Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies\n* Female of childbearing potential who are not surgically sterilized\u002Fpremenopausal\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug\n* Patients who have received electric shock therapy within 30 days prior to surgery\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery\n* Patients with severe dyskinesia in both on- and off-drug states","50 Years",{"count":101,"type":22},30,[26],"This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.",[105],"Parkinson Disease (PD)",[29,34],"2025-06-25",{"date":109,"type":39},"2025-06-29",{"date":111,"type":22},"2025-06-30",{"date":113,"type":22},"2030-12",{"name":45,"class":46},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":47},"100562837","phase-1-the-safety-tolerability-and-preliminary-efficacy-of-nouvneu001-for-early-onset-parkinsons-disease-100562837","NCT06608355","The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease","A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease","Inclusion Criteria:\n\n* Age 18-70 years old, male or female\n* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)\n* Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old\n* Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)\u002FMagnetic Resonance Imaging (MRI) scan.\n* Hoehn-Yahr staging for \"off\" episodes is 2 to 4\n* The MDS-UPDRS-III score in the \"off\" state \\>30, and positive for the Acute Levodopa Challenge Test (ALCT)\n* Acceptable laboratory test results during screening and prior to transplantation\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study; Patients with surgical contraindications or other neurosurgical contraindications\n* Patients who have a previous head CT\u002FMRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery\n* Patients with a history of severe cardiovascular and cerebrovascular diseases\n* Patients with a history of malignant tumors\n* Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF\n* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery\n* Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF\n* Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently\n* Patients who have used botulinum toxin within 6 months prior to signing the ICF\n* Patients with active epilepsy or currently on anti-epileptic drugs\n* Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \\> 3; poor compliance, inability to accurately keep diary, and\u002For inability to sign ICF due to dementia\n* Patients with severe depression or with severe anxiety\n* Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose\n* Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)\n* Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number \\> detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes\n* Patients with alcohol addiction or positive for drug of abuse testing\n* Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies\n* Female of childbearing potential who are not surgically sterilized\u002Fpremenopausal\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug\n* Patients who have received electric shock therapy within 30 days prior to surgery\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery\n* Patients with poor compliance based on clinical evaluation of the investigator\n* Patients who are being treated with drugs such as apomorphine, or levodopa\u002Fcarbidopa infusion therapy\n* Patients with severe dyskinesia in both on- and off-drug states",{"count":5,"type":22},[25],"The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:\n\nWhat medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?\n\nParticipants will:\n\nBe injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.\n\nTake immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.",[126],"Early-onset Parkinson's Disease",[126,34],"2024-11-04",{"date":130,"type":39},"2024-11-07",{"date":132,"type":39},"2024-08-23",{"date":134,"type":22},"2027-03",{"name":45,"class":46},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":97,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":19,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":103,"conditions":145,"keywords":146,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100528969","phase-1-the-safety-tolerability-and-efficacy-of-nouvneu001-for-parkinsons-disease-100528969","NCT06167681","The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease","Inclusion Criteria:\n\n* Age 50-75 years old, male or female\n* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)\n* Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)\n* Diagnosis of Parkinson's Disease made between 4 to 20 years ago\n* Medically suitable for neurosurgery under anesthesia and able to participate in Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan.\n* Hoehn-Yahr staging for \"off\" episodes is 2.5 to 4\n* The MDS-UPDRS Part III (MDS-UPDRS-III) score in the \"off\" state \\> 35, and positive for the Acute Levodopa Challenge Test (ALCT)\n* Acceptable laboratory test results during screening and prior to transplantation\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Patients who have had previous pallidotomy, deep brain stimulation (DBS) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study\n* Patients who have a previous head CT\u002FMRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.\n* Patients with a history of severe cardiovascular and cerebrovascular diseases\n* Patients with a history of malignant tumors\n* Patients who have had previous cellular therapy\n* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery\n* Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF\n* Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently;\n* Patients who have used botulinum toxin within 6 months prior to signing the ICF\n* Patients with active epilepsy or currently on anti-epileptic drugs\n* Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \\> 3; poor compliance, inability to accurately keep diary, and\u002For inability to sign ICF due to dementia\n* Patients with severe depression or with severe anxiety during screening;\n* Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose\n* Patients with surgical contraindications, or with other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications\n* Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)\n* Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number \\> detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes;\n* Patients with alcohol addiction or positive for drug of abuse testing\n* Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies;\n* Female of childbearing potential who are not surgically sterilized\u002Fpremenopausal\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug\n* Patients who have received electric shock therapy within 30 days prior to surgery\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery\n* Patients with poor compliance based on clinical evaluation of the investigator\n* Patients who are being treated with drugs such as apomorphine, or levodopa\u002Fcarbidopa infusion therapy\n* Patients with severe dyskinesia in both on- and off-drug states",{"count":143,"type":22},40,[25,26],[29],[29,34],"2024-10-30",{"date":149,"type":39},"2024-11-01",{"date":151,"type":39},"2024-01-17",{"date":153,"type":22},"2029-07",{"name":45,"class":46},2,""]