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

Nuwacell Biotechnologies

Status and phase: Enrolling; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Allogeneic dopaminergic neural precursor cell(NCR201)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06978920

NCR201-2001

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Low Dose

Experimental group

Description:

MRI-guided bilateral stereotactic cell implantation

Treatment:

Drug: Allogeneic dopaminergic neural precursor cell(NCR201)

High Dose

Experimental group

Description:

MRI-guided bilateral stereotactic cell implantation

Treatment:

Drug: Allogeneic dopaminergic neural precursor cell(NCR201)