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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNuwacell Biotechnologies Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Allogeneic dopaminergic neural precursor cell(NCR201)

    Drug

    Bilateral implantation

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Low DoseExperimental treatment 1 intervention
Group B: High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events.

Safety and tolerability

Time frame
Within 24 weeks post-transplantation

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.

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

Time frame
Within 24 months post-transplantation
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.

Higher scores mean a worse outcome.

Time frame
Within 24 months post-transplantation
3

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

Comprehensive clinical assessment for examining the improvements in Parkinson disease.

Time frame
Within 24 months post-transplantation
4

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

Comprehensive clinical assessment for examining the improvements in mental state.

Time frame
Within 24 months post-transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.