A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-06

Study Completion Date

2028-12-01

Brief Summary

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The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose

MRI-guided bilateral stereotactic cell implantation

Group Type EXPERIMENTAL

Allogeneic dopaminergic neural precursor cell(NCR201)

Intervention Type DRUG

Bilateral implantation

High Dose

MRI-guided bilateral stereotactic cell implantation

Group Type EXPERIMENTAL

Allogeneic dopaminergic neural precursor cell(NCR201)

Intervention Type DRUG

Bilateral implantation

Interventions

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Allogeneic dopaminergic neural precursor cell(NCR201)

Bilateral implantation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No