A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic dopaminergic neural precursor cell(NCR201).
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Detailed description
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.
Interventions
- Drug Allogeneic dopaminergic neural precursor cell(NCR201)
Bilateral implantation
Primary outcome measures
- Incidence and severity of adverse events. [Time frame: Within 24 weeks post-transplantation]
Secondary outcome measures (9)
- 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. [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. [Time frame: Within 24 months post-transplantation]
- Assessment of changes in Hoehn & Yahr scale in comparison with baseline values. [Time frame: Within 24 months post-transplantation]
- Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values. [Time frame: Within 24 months post-transplantation]
- Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values. [Time frame: Within 24 months post-transplantation]
- Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values. [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. [Time frame: Within 24 months post-transplantation]
- Patient L-dopa equivalent dose compared with baseline. [Time frame: Within 24 months post-transplantation]
- Incidence and severity of adverse events. [Time frame: Within 24 months post-transplantation]
Eligibility criteria
Inclusion criteria
- 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;
- Able to undergo PET/CT/MRI detection;
Exclusion criteria
- 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;
- Patients with other serious systemic diseases;
- Past or current metastatic malignant tumors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of USTC — Hefei
Identifiers
NCT: NCT06978920 · NCR201-2001