Health TrialsbyHealthPanel

The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease

ConditionParkinson Disease (PD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsoriRegene Therapeutics Co., Ltd.

About this trial

This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50-75 years old, male or female

Able to understand the rationale of the clinical trial and sign informed consent form (ICF)

Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)，Parkinson's disease history of ≥ 4 years

Medically suitable for neurosurgery under anesthesia and able to participate in Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan

Disqualifiers

Atypical or secondary Parkinson's syndrome to be caused by drugs, metabolic disorders or other reasons

The patients who have a previous history of PD-related brain surgery and have been judged by the investigator to pose significant risks or impact the assessment, or patients with contraindications for magnetic resonance imaging, or those who have been assessed by the investigator as having any contraindications for surgery or anesthesia, or patients who have received other surgeries that the investigator consider might affect their participation in this study

There were obvious abnormalities in the cranial CT/MRI examination

Those who have a history of severe cardiovascular diseases within one year prior to screening

Trial design

Design model

Sequential

Treatments tested in this trial

  • Human Dopaminergic Progenitor Cells

    Biological/Vaccine

    Single injection of Human Dopaminergic Progenitor Cells into the putamen/striatum region of brain.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NouvNeu001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Motor Function

Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ score from baseline to 24 weeks and 48 weeks post-transplant. MDS-UPDRS Part III assesses the motor signs of PD, a higher score indicates more severe symptoms of PD.

Time frame
24 weeks and 48 weeks post-transplant

Secondary outcomes

1

The Motor Function and Non-motor Function

Changes in MDS-UPDRS Part I-IV Score from baseline to 48 weeks and 96 weeks post-transplant. A higher score indicates more severe symptoms or worse health.

Time frame
48 weeks and 96 weeks post-transplant
2

Continued Safety and Tolerability

Incidence and severity of AEs and SAEs within 96 weeks and 5 years post-transplant.

Time frame
96 weeks and 5 years post-transplant

Other outcomes

Sponsors and contacts

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

iRegene Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: