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

NCT03128450 | Unknown Phase 2 DMC

• 1 other identifier: Second Affiliated Hospital
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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,

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Neural stem cell; Nasal delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• motor function index

  baseline and 16, 28 weeks

• Non-motor function score:cognitive function

  baseline and 16, 28 weeks

• Non-motor function score:smell

  baseline and 16, 28 weeks

• Non-motor function score:fatigue

  baseline and 16, 28 weeks

• Non-motor function score:emotion

  baseline and 16, 28 weeks

Other Outcomes (1)

• PD therapy drugs

  baseline and 16, 28 weeks

Study Arms (1)

h-NSC arm

EXPERIMENTAL

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

Interventions

human neural stem cell BIOLOGICAL

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

h-NSC arm

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Related 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.

  PMID: 24910427 RESULT

• Kefalopoulou Z, Politis M, Piccini P, Mencacci N, Bhatia K, Jahanshahi M, Widner H, Rehncrona S, Brundin P, Bjorklund A, Lindvall O, Limousin P, Quinn N, Foltynie T. Long-term clinical outcome of fetal cell transplantation for Parkinson disease: two case reports. JAMA Neurol. 2014 Jan;71(1):83-7. doi: 10.1001/jamaneurol.2013.4749.

  PMID: 24217017 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jie Li

  Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: April 25, 2017
• Study Start: April 15, 2017
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-05

Locations

CN (1)