A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient

Parkinson Disease Clinical Trial

— hNSCPD  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03128450
• Other study ID #: Second Affiliated Hospital
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: February 9, 2017
• Last updated: September 13, 2017
• Start date: April 15, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: May 2017
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: November 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Biological:
• human neural stem cell
human neural stem cell: 100ul/vessel,2 vessel/one bag,=2×10 6cells/vessel

Locations

Country	Name	City	State
China	Department of Neurology, Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (2)

Hallett PJ, Cooper O, Sadi D, Robertson H, Mendez I, Isacson O. Long-term health of dopaminergic neuron transplants in Parkinson's disease patients. Cell Rep. 2014 Jun 26;7(6):1755-61. doi: 10.1016/j.celrep.2014.05.027. Epub 2014 Jun 6. — View Citation

Kefalopoulou Z, Politis M, Piccini P, Mencacci N, Bhatia K, Jahanshahi M, Widner H, Rehncrona S, Brundin P, Björklund A, Lindvall O, Limousin P, Quinn N, Foltynie T. Long-term clinical outcome of fetal cell transplantation for Parkinson disease: two case — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PD therapy drugs	Reduction rate of PD therapy drugs	baseline and 16, 28 weeks
Primary	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%	Baseline and 16, 28 weeks
Secondary	motor function index	Hoehn-Yahr modified score	baseline and 16, 28 weeks
Secondary	Non-motor function score:cognitive function	Minimum Mental State Examination and Montreal Cognitive Assessment to assess cognitive function	baseline and 16, 28 weeks
Secondary	Non-motor function score:smell	Argentina Hyposmia Rating Scales is used to detect the smell	baseline and 16, 28 weeks
Secondary	Non-motor function score:fatigue	Fatigue Severity Scale to assess the extent of fatigue	baseline and 16, 28 weeks
Secondary	Non-motor function score:emotion	Hamilton Depression Scale to evaluate the degree of depression, Hamilton Anxiety Scale to evaluate the degree of anxiety	baseline and 16, 28 weeks
Secondary	Non-motor function score:non-motor symptoms	non-motor symptoms in PD patients is evaluated used Non-motor Symptoms Questionnaire	baseline and 16, 28 weeks
Secondary	Non-motor function score:autonomic symptoms	The scale for outcomes in PD for autonomic symptoms to assess autonomic dysfunction	baseline and 16, 28 weeks
Secondary	Non-motor function score:the quality of life.	The 39-item Parkinson's disease questionnaire to assess the quality of life.	baseline and 16, 28 weeks
Secondary	Immunological index	CD3(%),CD4(%),CD8(%),Treg cells(%)	baseline and 16, 28 weeks
Secondary	Imaging index	Magnetic Resonance Imaging or positron emission tomography	baseline and 16, 28 weeks
Secondary	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.	baseline and 16, 28 weeks
Secondary	Biochemical routine examination	Biochemical routine examination includes liver function, renal function, blood glucose, blood lipid	baseline and 16, 28 weeks
Secondary	Safety index	Adverse Event and Serious Adverse Event	1,2,3,4,weeks and 16, 28 weeks