About this trial
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages between 40 and 75 years;
Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
Disease history over 5 years;
Stable dose of dopamine treatment;
Disqualifiers
Patients who have previously undergone brain surgery;
Past use of stem cell therapy or participation in stem cell clinical research;
Cognitive impairment;
History of mental disorders;
Trial design
Sequential
Treatments tested in this trial
Allogeneic dopaminergic neural precursor cell(NCR201)
DrugBilateral implantation
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events.
Safety and tolerability
Secondary outcomes
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Higher scores mean a worse outcome.
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Sponsors and contacts
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