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NCT Number: NCT06978920

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

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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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Location status: Recruiting

Location contact

The First Affiliated Hospital of USTC

CONTACT

[email protected]

0551-96512

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allogeneic dopaminergic neural precursor cell(NCR201)

Drug

Bilateral implantation

Primary outcomes

  1. Incidence and severity of adverse events.

    Time frame: Within 24 weeks post-transplantation

    Safety and tolerability

Secondary outcomes

  1. 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.

    Time frame: Within 24 months post-transplantation

    Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.

  2. 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.

    Time frame: Within 24 months post-transplantation

    Higher scores mean a worse outcome.

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

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in Parkinson disease.

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

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in mental state.

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

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in mental state.

  6. Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.

    Time frame: Within 24 months post-transplantation

    Comprehensive clinical assessment for examining the improvements in activity of daily living.

  7. Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.

    Time frame: Within 24 months post-transplantation

    Evidence of cell survival

  8. Patient L-dopa equivalent dose compared with baseline.

    Time frame: Within 24 months post-transplantation

    Measure of dopaminergic drug dose

  9. Incidence and severity of adverse events.

    Time frame: Within 24 months post-transplantation

    Safety and tolerability

Sponsors and collaborators

Lead sponsor

Nuwacell Biotechnologies Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 18, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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