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

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.
 
ClinicalTrials.gov Identifier: NCT03119636
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date April 18, 2017
Estimated Study Start Date  ICMJE May 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Biological: NPC transplantation
    The cells are stereotactically implanted in the striatum.
  • Drug: Levodopa
    Levodopa is used depending on the patient's condition
Study Arms  ICMJE
  • Experimental: NPC transplantation
    The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation
    Interventions:
    • Biological: NPC transplantation
    • Drug: Levodopa
  • Experimental: HLA-matched NPC transplantation
    The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation
    Interventions:
    • Biological: NPC transplantation
    • Drug: Levodopa
  • Experimental: HLA-non-matched NPC transplantation
    The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation
    Interventions:
    • Biological: NPC transplantation
    • Drug: Levodopa
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119636
Other Study ID Numbers  ICMJE ChineseASZQ-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qi Zhou, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE The First Affiliated Hospital of Zhengzhou University
Investigators  ICMJE
Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP