A Phase 1/2 interventional study of NPC transplantation and Levodopa in Parkinson's Disease, sponsored by Chinese Academy of Sciences. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Chinese Academy of Sciences · Phase 1/2, Interventional, and Treatment
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.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients will receive Levodopa combined with a regular neural precursor cell (NPC) transplantation
Biological: NPC transplantation · Drug: Levodopa
The patients will receive Levodopa combined with a HLA-matched neural precursor cell (NPC) transplantation
Biological: NPC transplantation · Drug: Levodopa
The patients will receive Levodopa combined with a HLA-non-matched neural precursor cell (NPC) transplantation
Biological: NPC transplantation · Drug: Levodopa
The cells are stereotactically implanted in the striatum.
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
Number of subjects with adverse events such as the evidence of graft failure or rejection
Time frame: 6 months
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 12 months
Plan to share: Undecided
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Sciences