Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease

NCT03119636 | Unknown Phase 1 DMC

• 1 other identifier: ChineseASZQ-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of intracerebral transplantation of human embryonic stem cells-derived neural precursor cells in patients with Parkinson's Disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination

  Number of subjects with adverse events such as the evidence of graft failure or rejection

  6 months

Secondary Outcomes (3)

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline

  Baseline and 12 months

• Change in DATscan from baseline

  Baseline and 12 months

• Change in Hoehn and Yahr Stage from baseline

  Baseline and 12 months

Study Arms (3)

NPC transplantation

EXPERIMENTAL

The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation

Biological: NPC transplantation; Drug: Levodopa

HLA-matched NPC transplantation

EXPERIMENTAL

The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation

Biological: NPC transplantation; Drug: Levodopa

HLA-non-matched NPC transplantation

EXPERIMENTAL

The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation

Biological: NPC transplantation; Drug: Levodopa

Interventions

NPC transplantation BIOLOGICAL

The cells are stereotactically implanted in the striatum.

HLA-matched NPC transplantation; HLA-non-matched NPC transplantation; NPC transplantation

Levodopa DRUG

Levodopa is used depending on the patient's condition

HLA-matched NPC transplantation; HLA-non-matched NPC transplantation; NPC transplantation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Parkinson's disease patients，a history over 5 years，females or males;
• Cannot effectively control the PD or tolerate the side effects of drugs;
• Hoehn and Yahr Stage 3 or 4 in the off state at screening
• Age between 50 and 80 years;
• Dopamine is effective or once;
• Sign the informed consent

You may not qualify if:

• Atypical Parkinsonian syndrome or only having tremor syndrome;
• Having been done pallidotomy, DBS, striatum or extrapyramidal surgery;
• Subjects are using apomorphine or anticoagulant;
• Subjects used immunosuppressant or antipsychotic drugs in last 3 months;
• Subjects used botulinum toxin, phenol, or other drugs for the treatment of dystonia or muscle cramps in last 6 months;
• During the period of active epilepsy preventing epilepsy with antiepileptic;
• Coagulant function abnormality or other obviously abnormal laboratory test results;
• Having skin basal cell carcinoma or cervical cancer and other pre-cancerous lesions;
• Subject has a history of chronic alcohol or drug abuse ;
• Pregnancy or lactation;
• Subjects participated in other clinical trials in recent 3 months;
• Subject is considered as dementia, a serious mental disorder (depression or mania), and personality or behavioral disorders through cognitive and behavioral test;
• Cannot cooperate on the research;
• Severe brain atrophy, or existing brain injury such as cerebral infarction, cerebral vascular malformation or trauma;
• Severe systemic diseases;

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (1)

• Wang YK, Zhu WW, Wu MH, Wu YH, Liu ZX, Liang LM, Sheng C, Hao J, Wang L, Li W, Zhou Q, Hu BY. Human Clinical-Grade Parthenogenetic ESC-Derived Dopaminergic Neurons Recover Locomotive Defects of Nonhuman Primate Models of Parkinson's Disease. Stem Cell Reports. 2018 Jul 10;11(1):171-182. doi: 10.1016/j.stemcr.2018.05.010. Epub 2018 Jun 14.

  PMID: 29910127 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Zhou Qi, Doctor

  Institute of Zoology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Liu, Doctor

CONTACT

+86-01064807858; wangliu@ioz.ac.cn

Hao Jie, Doctor

CONTACT

+86-01062558737; haojie@ioz.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Institute of zoology, Chinese academy of sciences, and vice president of medical school， University of Chinese academy of sciences

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 18, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2020
• Last Updated: April 18, 2017

Record last verified: 2016-09

Locations

CN (1)