A Phase 1 interventional study of Allogeneic dopaminergic neural precursor cell(NCR201) in Parkinson Disease, sponsored by Nuwacell Biotechnologies Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Nuwacell Biotechnologies Co., Ltd. · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 48 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Nuwacell Biotechnologies Co., Ltd. is the lead sponsor of 9 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
MRI-guided bilateral stereotactic cell implantation
Drug: Allogeneic dopaminergic neural precursor cell(NCR201)
MRI-guided bilateral stereotactic cell implantation
Drug: Allogeneic dopaminergic neural precursor cell(NCR201)
Bilateral implantation
Incidence and severity of adverse events.
Safety and tolerability
Time frame: Within 24 weeks post-transplantation
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.
Time frame: Within 24 months post-transplantation
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.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Time frame: Within 24 months post-transplantation
Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in activity of daily living.
Time frame: Within 24 months post-transplantation
Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Evidence of cell survival
Time frame: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Measure of dopaminergic drug dose
Time frame: Within 24 months post-transplantation
Incidence and severity of adverse events.
Safety and tolerability
Time frame: Within 24 months post-transplantation
Plan to share: No
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Nuwacell Biotechnologies Co., Ltd.