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

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].
Publications

Administrative Information

NCT number NCT03119636
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03119636
Other study identifiers
Name ChineseASZQ-003
Source weblink https://clinicaltrials.gov/show/NCT03119636
Regulatory body approval
Name National Health Commission of the PRC;National medical products administration
Country
China
Approval number CMR-20161213-1001
Study sites
Public contact
Email wangliu@ioz.ac.cn
Public email wangliu@ioz.ac.cn
First name Liu
Last name Wang
Country
China
Sponsors Chinese Academy of Sciences
Collaborators

Cells

Source pluripotent stem cell lines
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.

Recruitment

Recruitment Status Unknown Status
Estimated number of participants 50
Contact institutions/departments