Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease

This is a single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD).

Inclusion Criteria:40-70 years old, with more than 5 years of idiopathic PD historyUPDRS-III off-time scores ≤49MMSE scores ≥24HAMD-17 scores < 25H-Y on-time scores ≤4reactive to levodopa or dopa agonistsPD medication dose is stable for more than 2 monthsno general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluationno abnormalities affecting cell transplantation by cranial MRIno participation of other clinical trials 3 months before signing the informed consentExclusion Criteria:secondary PD or Parkinson's syndromesubcutaneous apomorphine treatmentscoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consenthistory of seizures or prophylactic application of antiepileptic drugsother serious central nervous system disordershistory of stem cell therapysubject who had undergone a major surgery within 3 months and will undergo a major surgery within the next 6 months prior to signing informed consentautoimmune disease or current use of Immunosuppressantssubjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction blockpoorly controlled hypertension, diabetes mellitus, or comorbid endocrine system disorders, pulmonary disorders, gastrointestinal system disorders, serious infections, malignancies, etc.positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or Treponema pallidum antibodyabnormalities in liver or kidney function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) or creatinine(Cr) are less than 1.5 times the upper limit of normal, or serum albumin < 30.0 g/Labnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count < 80 × 10^9/Linability to undergo MRI and positron emission tomography (PET) examinationssubject with severe allergieswomen of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, who are unwilling to take contraception during the trialpregnant or lactating femalesother conditions deemed by the investigator to be inappropriate for enrollment.