A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient (hNSCPD)
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|ClinicalTrials.gov Identifier: NCT03128450|
Recruitment Status : Unknown
Verified May 2017 by Chun-Feng Liu, Second Affiliated Hospital of Soochow University.
Recruitment status was: Enrolling by invitation
First Posted : April 25, 2017
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Biological: human neural stem cell||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-Label，Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease|
|Actual Study Start Date :||April 15, 2017|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||November 1, 2018|
Experimental: h-NSC arm
human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel，produced by Shanghai Angecon Biotechology Cooperate.
One enrolled PD patient was given 2 vessels h-NSC througth nasal cavity weekly for 4 weeks。Total cell number will be over ≥4×10 6cells for one time.
Biological: human neural stem cell
human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel
- The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline [ Time Frame: Baseline and 16, 28 weeks ]
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％
- motor function index [ Time Frame: baseline and 16, 28 weeks ]Hoehn-Yahr modified score
- Non-motor function score:cognitive function [ Time Frame: baseline and 16, 28 weeks ]Minimum Mental State Examination and Montreal Cognitive Assessment to assess cognitive function
- Non-motor function score:smell [ Time Frame: baseline and 16, 28 weeks ]Argentina Hyposmia Rating Scales is used to detect the smell
- Non-motor function score:fatigue [ Time Frame: baseline and 16, 28 weeks ]Fatigue Severity Scale to assess the extent of fatigue
- Non-motor function score:emotion [ Time Frame: baseline and 16, 28 weeks ]Hamilton Depression Scale to evaluate the degree of depression, Hamilton Anxiety Scale to evaluate the degree of anxiety
- Non-motor function score:non-motor symptoms [ Time Frame: baseline and 16, 28 weeks ]non-motor symptoms in PD patients is evaluated used Non-motor Symptoms Questionnaire
- Non-motor function score:autonomic symptoms [ Time Frame: baseline and 16, 28 weeks ]The scale for outcomes in PD for autonomic symptoms to assess autonomic dysfunction
- Non-motor function score:the quality of life. [ Time Frame: baseline and 16, 28 weeks ]The 39-item Parkinson's disease questionnaire to assess the quality of life.
- Immunological index [ Time Frame: baseline and 16, 28 weeks ]CD3(%)，CD4(%)，CD8(%)，Treg cells(%)
- Imaging index [ Time Frame: baseline and 16, 28 weeks ]Magnetic Resonance Imaging or positron emission tomography
- Blood routine examination [ Time Frame: baseline and 16, 28 weeks ]Blood routine examination includes the total number of red blood cells, hemoglobin, total number of white blood cells, white blood cells count, platelet count.
- Biochemical routine examination [ Time Frame: baseline and 16, 28 weeks ]Biochemical routine examination includes liver function, renal function, blood glucose, blood lipid
- Safety index [ Time Frame: 1,2,3,4,weeks and 16, 28 weeks ]Adverse Event and Serious Adverse Event
- PD therapy drugs [ Time Frame: baseline and 16, 28 weeks ]Reduction rate of PD therapy drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128450
|Department of Neurology, Second Affiliated Hospital of Soochow University|
|Suzhou, Jiangsu, China, 215004|
|Principal Investigator:||Jie Li||Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou|