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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
human Amniotic Epithelial Stem Cells
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDose limiting toxicity (DLT)
The occurrence of DLT.
Time frame: 12 months
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI)
According to CTCAE V5.0, AE, SAE and AESI evaluated by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions. AESI is defined as intracranial infection, hemorrhage, rejection, edema, as well as acute allergic reactions and ectopic mass formation associated with the therapy.
Time frame: 12 Months
Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Time frame: 12 months
Change from baseline in the UPDRS off-time total scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Time frame: 12 months
Change from baseline in the UPDRS on-time total scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
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Time frame: 12 months
Change from baseline in sum of the UPDRS-II and UPDRS-III scores
UPDRS is used for evaluating the impairment and disability associated with PD. It consists of 4 sections: I Mentation, behavior, and mood; II Activities of daily living (ADLs); III Motor; and IV Complications.The UPDRS score ranges from 0 to 199, with higher score indicating greater disability
Time frame: 12 months
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores
The PDQ-39 is a self-completed questionnaire assessing how often people with Parkinson's experience difficulties across 8 dimensions of daily living with 39 questions . Questions are answered using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each scores range from 0 = never have difficulty to 100 = always have difficulty.The higher the score, the lower the quality of life of PD patients.
Time frame: 12 months
Changes in the Hamilton Depression-17 (HAMD-17) Scale scores
The HAMD-17 Scale is the most widely used scale in clinical evaluation of depression in PD patients. This project takes 8 points as the critical value of depression, and the total score over 35 points is considered as severe depression, more than 20 points is likely to be diagnosed with depression, less than 8 points is not depressed.
Time frame: 12 months
Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1), sleep onset and maintenance insomnia (items 2 and 3), nocturnal restlessness (items 4 and 5), nocturnal psychosis (items 6 and 7), nocturia (items 8 and 9), nocturnal motor symptoms (items 10-13), sleep refreshment (item 14) and daytime dozing (item 15). Scores range from 0 (poorly or often) to 10 (very good or never), with a total score of \<90 indicating sleep disturbance, with higher scores indicating better sleep quality.
Time frame: 12 months
Changes from baseline in the Hoehn and Yahr scale (H-Y)
The Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients.
Time frame: 12 months
Changes from baseline in the Mini-Mental State Examination (MMSE)
The total score of tne MMSE ranges from 0 to 30, with a higher score indicating better function for Cognitive assessment.
Time frame: 12 months