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

This study is currently recruiting participants.
Verified September 2016 by Qi Zhou, Chinese Academy of Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03119636
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Biological: NPC transplantation Drug: Levodopa Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Qi Zhou, Chinese Academy of Sciences:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events (TEAEs), severe TEAEs as assessed by head MRI and blood examination [ Time Frame: 6 months ]
    Number of subjects with adverse events such as the evidence of graft failure or rejection


Secondary Outcome Measures:
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline [ Time Frame: Baseline and 12 months ]
    The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.

  • Change in DATscan from baseline [ Time Frame: Baseline and 12 months ]
    DATscan is an imaging technology that uses small amounts of a radioactive drug to help determine how much dopamine is available in a person's brain.Its principle is based on using of radiopharmaceutical, which bind to dopamine transporters (DAT).

  • Change in Hoehn and Yahr Stage from baseline [ Time Frame: Baseline and 12 months ]
    The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress mainly by observing balance and walk.


Estimated Enrollment: 50
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC transplantation
The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation
Biological: NPC transplantation
The cells are stereotactically implanted in the striatum.
Drug: Levodopa
Levodopa is used depending on the patient's condition
Experimental: HLA-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation
Biological: NPC transplantation
The cells are stereotactically implanted in the striatum.
Drug: Levodopa
Levodopa is used depending on the patient's condition
Experimental: HLA-non-matched NPC transplantation
The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation
Biological: NPC transplantation
The cells are stereotactically implanted in the striatum.
Drug: Levodopa
Levodopa is used depending on the patient's condition

Detailed Description:
This study is a Phase I/II, open-label, non randomized clinical trial. The study will enroll 50 patients for cell injection, administering a single dose of neural precursor cells by stereotaxic intra-striatal injection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Atypical Parkinsonian syndrome or only having tremor syndrome;
  2. Having been done pallidotomy, DBS, striatum or extrapyramidal surgery;
  3. Subjects are using apomorphine or anticoagulant;
  4. Subjects used immunosuppressant or antipsychotic drugs in last 3 months;
  5. Subjects used botulinum toxin, phenol, or other drugs for the treatment of dystonia or muscle cramps in last 6 months;
  6. During the period of active epilepsy preventing epilepsy with antiepileptic;
  7. Coagulant function abnormality or other obviously abnormal laboratory test results;
  8. Having skin basal cell carcinoma or cervical cancer and other pre-cancerous lesions;
  9. Subject has a history of chronic alcohol or drug abuse ;
  10. Pregnancy or lactation;
  11. Subjects participated in other clinical trials in recent 3 months;
  12. Subject is considered as dementia, a serious mental disorder (depression or mania), and personality or behavioral disorders through cognitive and behavioral test;
  13. Cannot cooperate on the research;
  14. Severe brain atrophy, or existing brain injury such as cerebral infarction, cerebral vascular malformation or trauma;
  15. Severe systemic diseases;
  16. Severe dyskinesia or frequent "OFF" or "ON" states
  17. Severe infectious diseases (eg HIV, HCV, HBV, syphilis positive)
  18. Not suitable to participate in this clinical trial assessed by other physicians
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119636


Contacts
Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn

Locations
China, Henan
The first affiliated hospital of Zhengzhou university Recruiting
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Chinese Academy of Sciences
The First Affiliated Hospital of Zhengzhou University
Investigators
Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences
  More Information

Responsible Party: Qi Zhou, Deputy director of Institute of zoology, Chinese academy of sciences, and vice president of medical school, University of Chinese academy of sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03119636     History of Changes
Other Study ID Numbers: ChineseASZQ-003
First Submitted: April 6, 2017
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs