This Pilot study will evaluate the safety and Efficacy of an investigational cell transplantation therapy, h-NSC, in patients with Parkinson's disease, through nasal drug delivery, a new delivery way. All patients will receive the therapy, which consists of human neural stem cells,
h-NSC is a cellular therapeutic consisting of human fetal neural stem cells (h-NSC). h-NSC injection will be delivered through nasal way for patients with Parkinson's disease (PD). The study will enroll 12 moderate to severe PD patients to be treated with the cell injection therapy at the same dose. The total therapy course will be four weeks,one dose for one week. The follow up will be two times within 24 weeks after finishing the treatment. The main objective of the study is to evaluate the efficacy and safety of the cell transplantation by this new delivery way.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
human neural stem cell: 100ul/vessel,2 vessel/one bag,≥2×10 6cells/vessel
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline
Improvement rate of UPDRS motor score defined as below: Reduction rate =(baseline score 16, 28 weeks score after therapy)/ baseline score×100%. Based on reduction rate, the efficacy can be defined as complete remission, partial remission, effective and invalid The reduction rate will be 100%, \>50%, \>25-50%, ≤ 25% for complete remission, partial remission, effective and invalid. The improvement rate =\[(complete+partial+effective patient number)/total patient number\]×100%
Time frame: Baseline and 16, 28 weeks
motor function index
Hoehn-Yahr modified score
Time frame: baseline and 16, 28 weeks
Non-motor function score:cognitive function
Minimum Mental State Examination and Montreal Cognitive Assessment to assess cognitive function
Time frame: baseline and 16, 28 weeks
Non-motor function score:smell
Argentina Hyposmia Rating Scales is used to detect the smell
Time frame: baseline and 16, 28 weeks
Non-motor function score:fatigue
Fatigue Severity Scale to assess the extent of fatigue
Time frame: baseline and 16, 28 weeks
Non-motor function score:emotion
Hamilton Depression Scale to evaluate the degree of depression, Hamilton Anxiety Scale to evaluate the degree of anxiety
Time frame: baseline and 16, 28 weeks
Non-motor function score:non-motor symptoms
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non-motor symptoms in PD patients is evaluated used Non-motor Symptoms Questionnaire
Time frame: baseline and 16, 28 weeks
Non-motor function score:autonomic symptoms
The scale for outcomes in PD for autonomic symptoms to assess autonomic dysfunction
Time frame: baseline and 16, 28 weeks
Non-motor function score:the quality of life.
The 39-item Parkinson's disease questionnaire to assess the quality of life.
Time frame: baseline and 16, 28 weeks
Immunological index
CD3(%),CD4(%),CD8(%),Treg cells(%)
Time frame: baseline and 16, 28 weeks
Imaging index
Magnetic Resonance Imaging or positron emission tomography
Time frame: baseline and 16, 28 weeks
Blood routine examination
Blood routine examination includes the total number of red blood cells, hemoglobin, total number of white blood cells, white blood cells count, platelet count.
Time frame: baseline and 16, 28 weeks
Biochemical routine examination
Biochemical routine examination includes liver function, renal function, blood glucose, blood lipid
Time frame: baseline and 16, 28 weeks
Safety index
Adverse Event and Serious Adverse Event
Time frame: 1,2,3,4,weeks and 16, 28 weeks