Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jingwen Wu, M.D.
wujingwendongfang@163.com
021-38804518
Time Frame
Start Date: 2023-02
Estimated Completion Date: 2026-02
Participants
Target number of participants: 18
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Shanghai East Hospital
Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China