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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC transplantation | Experimental | The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation |
|
| HLA-matched NPC transplantation | Experimental | The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation |
|
| HLA-non-matched NPC transplantation | Experimental | The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC transplantation | Biological | The cells are stereotactically implanted in the striatum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Liu, Doctor | Contact | +86-01064807858 | wangliu@ioz.ac.cn | |
| Hao Jie, Doctor | Contact | +86-01062558737 | haojie@ioz.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhou Qi, Doctor | Institute of Zoology, Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou university | Recruiting | Zhengzhou | Henan | 450052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29910127 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Levodopa | Drug | Levodopa is used depending on the patient's condition |
|
| Baseline and 12 months |
| Change in DATscan from baseline | 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). | Baseline and 12 months |
| Change in Hoehn and Yahr Stage from baseline | 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. | Baseline and 12 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |