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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03128450
• Date of registration: 09/02/2017
• Prospective Registration: Yes
• Primary sponsor: Second Affiliated Hospital of Soochow University
• Public title: A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient hNSCPD
• Scientific 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
• Date of first enrolment: April 15, 2017
• Target sample size: 12
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03128450
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Jie Li
• Affiliation: Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Biological: human neural stem cell

Primary Outcome(s)

The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline [Time Frame: Baseline and 16, 28 weeks]

Secondary Outcome(s)

Non-motor function score:autonomic symptoms [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:the quality of life. [Time Frame: baseline and 16, 28 weeks]

Immunological index [Time Frame: baseline and 16, 28 weeks]

Imaging index [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:fatigue [Time Frame: baseline and 16, 28 weeks]

Safety index [Time Frame: 1,2,3,4,weeks and 16, 28 weeks]

Blood routine examination [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:cognitive function [Time Frame: baseline and 16, 28 weeks]

Biochemical routine examination [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:emotion [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:non-motor symptoms [Time Frame: baseline and 16, 28 weeks]

motor function index [Time Frame: baseline and 16, 28 weeks]

Non-motor function score:smell [Time Frame: baseline and 16, 28 weeks]

Secondary ID(s)

Second Affiliated Hospital

Source(s) of Monetary Support

Please refer to primary and secondary sponsors