Trials Sponsors Conditions Drugs Pricing

Conditions

PARKINSON DISEASE (Disorder)Cell Therapy Human Induced Pluripotent Stem Cells Deep Brain Stimulation Phase 1 Clinical Trial Dopaminergic Progenitor Cells

Keywords

Parkinson DiseaseCell therapyHuman induced pluripotent stem cellsDeep brain stimulationPhase 1 clinical trialHypoimmune dopaminergic progenitor cellsPutaminal injectionHypoimmune cell product

Outcome Measures

Primary Outcomes (2)

Incidence of Adverse Events
To evaluate the safety and tolerability of stereotactic intracerebral injection of NCR201 by assessing the type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs).
From the time of cell infusion up to 12 months after NCR201 transplantation
Maximum Tolerated Dose (MTD) of NCR201
Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
Within 12 months after NCR201 transplantation

Secondary Outcomes (9)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
Baseline, 3 months, 6 months and 12 months after NCR201 transplantation

Study Arms (1)

NCR201 Treatment Group

EXPERIMENTAL

All enrolled participants will receive stereotactic putaminal injection of NCR201. This is a dose-escalation design.

Biological: NCR201

Interventions

NCR201Biological

NCR201 is human induced pluripotent stem cell (iPSC)-derived hypoimmune dopaminergic progenitor cell injection. It is administered via single stereotactic putaminal injection at dose level of either 4x10\^6 cells per side or 8x10\^6 cells per side. Product specification: 2.4x10\^7 cells /0.3 mL per vial, stored and transported under 2-8℃.

NCR201 Treatment Group

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged between 26 and 70 years (inclusive), male or female.
Diagnosed with primary Parkinson's disease (consistent with Chinese Parkinson's Disease Diagnostic Criteria, 2016 version). The subject has previously undergone intracranial deep brain stimulation (DBS) implantation surgery, with disease duration ≥ 5 years.

Sponsors & Collaborators

Nuwacell Biotechnologies Co., Ltd.
Industrylead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Jianguo Zhang, MDCONTACT+86 13601294613 zjguo73@126.com

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Jianguo Zhang, MD
Beijing Tiantan Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruidong Zhang

CONTACT

+86 18132430187 rdzhang@nuwacell.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: This is an open-label study. No masking is performed. All participants and study personnel know the intervention received.
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 19, 2026

First Posted

October 26, 2026

You may not qualify if:

Atypical or secondary Parkinsonism.
Subjects with persistent active infection, cerebrospinal fluid leak, or unhealed wounds in the previous brain surgical area; malfunction of implanted devices, electrode displacement, or other conditions judged by the investigator to pose significant risks to the subject or interfere with study assessments; subjects who are unable to safely complete protocol-specified MRI examinations under the conditions specified in the DBS system instructions and study site SOP (including but not limited to device/lead combinations that do not meet scanning requirements or other MRI contraindications); subjects with any contraindication to surgery or anesthesia as assessed by the investigator; or subjects with other prior surgical conditions deemed by the investigator to interfere with study participation.
Head CT/MRI demonstrating brain trauma, cerebrovascular malformation, hydrocephalus, brain tumor, basal ganglia cerebral infarction lesions or other brain injuries, severe cerebral atrophy, or imaging abnormalities in the striatum or other brain regions that substantially increase surgical risk.
Subjects with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to signing the informed consent form, or subjects who cannot discontinue antiplatelet agents or other anticoagulant agents for at least 5 days prior to surgery.
Subjects with any of the following: positive human immunodeficiency virus (HIV) antibody; positive Treponema pallidum antibody; positive hepatitis C virus (HCV) antibody with HCV RNA copy number greater than the lower limit of the assay normal range; positive hepatitis B virus (HBV) surface antigen with HBV DNA copy number greater than the lower limit of the assay normal range; active tuberculosis; or other active infections judged by the investigator that may interfere with subject participation or study outcomes.
Subjects with dementia or severe cognitive impairment at screening.
Subjects with a significant history of psychiatric disorders at screening, or suffering from severe depression.
Subjects who have participated in clinical trials of stem cell therapy or gene therapy for Parkinson's disease.
History of severe allergy or hypersensitivity reactions.
Subjects with alcohol addiction, or positive drug abuse screening test.
Lactating women; female subjects with pregnancy or oocyte donation plans from study initiation through the follow-up period; male subjects (or their partners) with fertility or sperm donation plans from study initiation through the follow-up period and refuse to take contraceptive measures.
Subjects with severe dyskinesia in the medication ON state.
Other conditions that, in the investigator's opinion, would render the subject unsuitable for this clinical study.

A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (1)

NCR201 Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (1)

NCR201 Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations