Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
Idiopathic Parkinson's Disease
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: 40-70 years old, with more than 5 years of idiopathic PD history UPDRS-III off-time scores ≤49 MMSE scores ≥24 HAMD-17 scores < 25 H-Y on-time scores ≤4 reactive to levodopa or dopa agonists PD medication dose is stable for more than 2 months no general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluation no abnormalities affecting cell transplantation by cranial MRI no participation of other clinical trials 3 months before signing the informed consent Exclusion Criteria: secondary PD or Parkinson's syndrome subcutaneous apomorphine treatment scoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14 history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent history of seizures or prophylactic application of antiepileptic drugs other serious central nervous system disorders history of stem cell therapy subject who had undergone a major surgery within 3 months and will undergo a major surgery within the next 6 months prior to signing informed consent autoimmune disease or current use of Immunosuppressants subjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction block poorly 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 antibody abnormalities 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/L abnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count < 80 × 10^9/L inability to undergo MRI and positron emission tomography (PET) examinations subject with severe allergies women of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, who are unwilling to take contraception during the trial pregnant or lactating females other conditions deemed by the investigator to be inappropriate for enrollment.
Sites / Locations
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Experimental
hAESCs treatment
hAESCs will be administration through Ommaya reservoir implanted into the lateral ventricle. The tolerability, safety, and efficacy will be examined of 4 monthly doses of hAESCs for 3 months followed by 2 doses every 3 months in dose escalation through 3 cohorts. Dose A (5×10^7 cells/dose) Dose B (1.0×10^8 cells/dose) Dose C (1.5×10^8 cells/dose).