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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
Sponsor:
Information provided by (Responsible Party):
Chun-Feng Liu, Second Affiliated Hospital of Soochow University

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date September 14, 2017
Actual Study Start Date  ICMJE April 15, 2017
Estimated Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
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%
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline [ Time Frame: Baseline and 3, 6 months ]
Improvement rate of UPDRS motor score defined as below: Reduction rate =(baseline score-3 or 6 months 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%
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • motor function index [ Time Frame: baseline and 3, 6 months ]
    Hoehn-Yahr modified score
  • Non-motor function score:cognitive function [ Time Frame: baseline and 3, 6 months ]
    Minimum Mental State Examination and Montreal Cognitive Assessment to assess cognitive function
  • Non-motor function score:smell [ Time Frame: baseline and 3, 6 months ]
    Argentina Hyposmia Rating Scales is used to detect the smell
  • Non-motor function score:fatigue [ Time Frame: baseline and 3, 6 months ]
    Fatigue Severity Scale to assess the extent of fatigue
  • Non-motor function score:emotion [ Time Frame: baseline and 3, 6 months ]
    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 3, 6 months ]
    non-motor symptoms in PD patients is evaluated used Non-motor Symptoms Questionnaire
  • Non-motor function score:autonomic symptoms [ Time Frame: baseline and 3, 6 months ]
    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 3, 6 months ]
    The 39-item Parkinson's disease questionnaire to assess the quality of life.
  • Immunological index [ Time Frame: baseline and 3, 6 months ]
    CD3(%),CD4(%),CD8(%),Treg cells(%)
  • Imaging index [ Time Frame: baseline and 3, 6 months ]
    Magnetic Resonance Imaging or positron emission tomography
  • Blood routine examination [ Time Frame: baseline and 3, 6 months ]
    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 3, 6 months ]
    Biochemical routine examination includes liver function, renal function, blood glucose, blood lipid
  • Safety index [ Time Frame: 1,2,3,4,5,6 weeks and 3, 6 months ]
    Adverse Event and Serious Adverse Event
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2017)
PD therapy drugs [ Time Frame: baseline and 16, 28 weeks ]
Reduction rate of PD therapy drugs
Original Other Pre-specified Outcome Measures
 (submitted: April 20, 2017)
PD therapy drugs [ Time Frame: baseline and 3, 6 months ]
Reduction rate of PD therapy drugs
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient
Official Title  ICMJE 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
Brief Summary 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,
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Biological: human neural stem cell
human neural stem cell: 100ul/vessel,2 vessel/one bag,≥2×10 6cells/vessel
Study Arms  ICMJE 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.

Intervention: Biological: human neural stem cell
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2018
Estimated Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient diagnosed with idiopathic PD, at least with two key symptoms (Static tremor, bradykinesia, rigidity ) , without any other evidence of Secondary Parkinson's syndrome.
  • Disease course ≥7 years,modified Hoehn-Yahr is 3-5 stage
  • Patient age ≥35 years
  • Patients receiving a stable dose of levodopa for at least 1 months with the expectation that the treatment will remain unchanged throughout the course of the study
  • The doses of levodopa ≥300mg •Signed informed consent form (ICF) by patient self or his law-in relationship before enrollment.

Exclusion Criteria:

  • Hepatic dysfunction(transaminase ≥1.5 normal range), Renal dysfunction(Cr>2.0mg/dl or 177μmol/L),Cardiac dysfunction or other severe systematic diseases etc.
  • Suffering malignancy or during anti-cancer treatment period.
  • Pregancy, lactation or possible pregancy and plan to pregancy patient
  • Attended other intervention clinical trial within 3 months aftre getting ICF, or during other ongoing intervention clinical trial
  • Investigator think inappropriate patient for this protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128450
Other Study ID Numbers  ICMJE Second Affiliated Hospital
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Will decisde if the IPD based on patient consent
Responsible Party Chun-Feng Liu, Second Affiliated Hospital of Soochow University
Study Sponsor  ICMJE Second Affiliated Hospital of Soochow University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jie Li Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou
PRS Account Second Affiliated Hospital of Soochow University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP