Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT03119636 |
Recruitment Status : Unknown
Verified September 2016 by Qi Zhou, Chinese Academy of Sciences.
Recruitment status was: Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Biological: NPC transplantation Drug: Levodopa | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
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 |
Estimated Study Start Date : | May 2017 |
Estimated Primary Completion Date : | November 2018 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
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 |
- 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
- 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.

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- Severe dyskinesia or frequent "OFF" or "ON" states
- Severe infectious diseases (eg HIV, HCV, HBV, syphilis positive)
- Not suitable to participate in this clinical trial assessed by other physicians

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
Contact: Wang Liu, Doctor | +86-01064807858 | wangliu@ioz.ac.cn | |
Contact: Hao Jie, Doctor | +86-01062558737 | haojie@ioz.ac.cn |
China, Henan | |
The first affiliated hospital of Zhengzhou university | Recruiting |
Zhengzhou, Henan, China, 450052 |
Principal Investigator: | Zhou Qi, Doctor | Institute of zoology, Chinese Academy of Sciences |
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 |
Other Study ID Numbers: |
ChineseASZQ-003 |
First Posted: | April 18, 2017 Key Record Dates |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |