The First Affiliated Hospital of USTC
Hefei, Anhui, China
Location status: Recruiting
NCT Number: NCT06978920
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Interested in participating?
Request Info40 year–75 year
All sexes
Interventional
Phase 1
Hefei, Anhui, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral implantation
Time frame: Within 24 weeks post-transplantation
Safety and tolerability
Time frame: Within 24 months post-transplantation
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Time frame: Within 24 months post-transplantation
Higher scores mean a worse outcome.
Time frame: Within 24 months post-transplantation
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Time frame: Within 24 months post-transplantation
Comprehensive clinical assessment for examining the improvements in mental state.
Time frame: Within 24 months post-transplantation
Comprehensive clinical assessment for examining the improvements in mental state.
Time frame: Within 24 months post-transplantation
Comprehensive clinical assessment for examining the improvements in activity of daily living.
Time frame: Within 24 months post-transplantation
Evidence of cell survival
Time frame: Within 24 months post-transplantation
Measure of dopaminergic drug dose
Time frame: Within 24 months post-transplantation
Safety and tolerability
Nuwacell Biotechnologies Co., Ltd.
Industry
A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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