General Information |
| 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. |
| 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. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2017-05-01 |
| End date (estimated) |
2020-12-31 |
| Clinical feature |
| Label |
Parkinson's disease |
| Link |
http://purl.obolibrary.org/obo/DOID_14330 |
| Description |
A synucleinopathy that has_material_basis_in degeneration of the central nervous system that often impairs motor skills, speech, and other functions.; Xref MGI. OMIM mapping confirmed by DO. [SN]. |
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| Publications |
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Administrative Information |
| NCT number |
NCT03119636 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03119636 |
| Other study identifiers |
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| Source weblink |
https://clinicaltrials.gov/show/NCT03119636 |
| Regulatory body approval |
| Name |
National Health Commission of the PRC;National medical products administration |
| Country |
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| Approval number |
CMR-20161213-1001 |
| Study sites |
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| Sponsors |
Chinese Academy of Sciences
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| Collaborators |
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Cells |
| Source pluripotent stem cell lines |
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| Which differentiated cell type is used |
| Label |
dopaminergic neuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000700 |
| Description |
A neuron that releases dopamine as a neurotransmitter. |
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Recruitment |
| Recruitment Status |
Unknown Status |
| Estimated number of participants |
50 |
| Contact institutions/departments |
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