NCT06978920

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
30mo left

Started Jun 2025

Longer than P75 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jun 2025Dec 2028

First Submitted

Initial submission to the registry

April 30, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 1, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

April 30, 2025

Last Update Submit

July 30, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events.

    Safety and tolerability

    Within 24 weeks post-transplantation

Secondary Outcomes (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.

    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.

    Within 24 months post-transplantation

  • Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.

    Within 24 months post-transplantation

  • Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.

    Within 24 months post-transplantation

  • +4 more secondary outcomes

Study Arms (2)

Low Dose

EXPERIMENTAL

MRI-guided bilateral stereotactic cell implantation

Drug: Allogeneic dopaminergic neural precursor cell(NCR201)

High Dose

EXPERIMENTAL

MRI-guided bilateral stereotactic cell implantation

Drug: Allogeneic dopaminergic neural precursor cell(NCR201)

Interventions

Allogeneic dopaminergic neural precursor cell(NCR201)DRUG

Bilateral implantation

High DoseLow Dose

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of USTC

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 18, 2025

Study Start

June 6, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

August 1, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)