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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    18
  • sponsor
    Shanghai East Hospital
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Updated on 17 November 2025
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Summary

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).

Description

hAESCs will be administration through the Ommaya reservoir implanted into the lateral ventricle of subjects with idiopathic PD.

This dose escalation will be followed by an exploratory expansion phase in 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).

Details
Condition Idiopathic Parkinson's Disease
Age 40years - 70years
Clinical Study IdentifierNCT05691114
SponsorShanghai East Hospital
Last Modified on17 November 2025

Eligibility

 Yes No Not Sure

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
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