Clinical trial NCT06978920: A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Nuwacell Biotechnologies Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Incidence and severity of adverse events.
timeFrame: Within 24 weeks post-transplantation
Secondary outcomes:
measure: 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.
timeFrame: Within 24 months post-transplantation
measure: 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.
timeFrame: Within 24 months post-transplantation
measure: Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
timeFrame: Within 24 months post-transplantation
measure: Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.
timeFrame: Within 24 months post-transplantation
measure: Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
timeFrame: Within 24 months post-transplantation
measure: Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.
timeFrame: Within 24 months post-transplantation
measure: Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
timeFrame: Within 24 months post-transplantation
measure: Patient L-dopa equivalent dose compared with baseline.
timeFrame: Within 24 months post-transplantation
measure: Incidence and severity of adverse events.
timeFrame: Within 24 months post-transplantation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
Study officials:
References: