A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease

iRegene Therapeutics Co., Ltd.1 site in 1 country6 target enrollmentAugust 23, 2024

ConditionsEarly-onset Parkinson's Disease

InterventionsHuman Dopaminergic Progenitor Cells

DrugsHuman Dopaminergic Progenitor Cells

Overview

Phase: Phase 1
Intervention: Human Dopaminergic Progenitor Cells
Conditions: Early-onset Parkinson's Disease
Sponsor: iRegene Therapeutics Co., Ltd.
Enrollment: 6
Locations: 1
Primary Endpoint: Safety and Tolerability
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:

What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?

Participants will:

Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.

Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.

Registry

clinicaltrials.gov

Start Date

August 23, 2024

End Date

March 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

iRegene Therapeutics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-70 years old, male or female
•Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
•Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old
•Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
•Hoehn-Yahr staging for "off" episodes is 2 to 4
•The MDS-UPDRS-III score in the "off" state \>30, and positive for the Acute Levodopa Challenge Test (ALCT)
•Acceptable laboratory test results during screening and prior to transplantation

Exclusion Criteria

•Atypical Parkinsonism
•Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study; Patients with surgical contraindications or other neurosurgical contraindications
•Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery
•Patients with a history of severe cardiovascular and cerebrovascular diseases
•Patients with a history of malignant tumors
•Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF
•Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery
•Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF
•Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently
•Patients who have used botulinum toxin within 6 months prior to signing the ICF